Senior Connectivity Firmware/Test Engineer 1 year freelance contract + extensions after Leuven, Belgium (2 days remote per week) Within our Personal Health R&D group, we want to capture the strong market growth in ICs for hearing aids and implants, hearables, wearables, and personal health monitoring applications, health IoT. Owing to our success, our department of 40+ engineers is growing, and we have challenging opportunities for software engineers. Our System-on-Chip products employ the latest Bluetooth Smart (BLE) or NFC with our experience in ultra-low power design. We develop the full software stack from driver-level all to way to turnkey applications, enabling our customers to build their products with minimum effort. Description of services: Unconditionally technically responsible for a subsystem, application Estimate the effort for your work and contribute to reviewing the estimates of peers Execute feasibility studies to underpin the estimations Create a design for the software Organize or contribute to (mutual) reviews of designs with colleagues and Software Architect Plan your assignments and report on progress Contribute to specifying and developing automated regression test frameworks. Document functional and performance specifications, test design documentation and develop the test strategy and test specifications. Work with the development team to develop and guide the implementation of module, systems and end to end tests (functional + performance testing) to fit in the test framework. Develop test automations using Python, Jenkins. Experience: Master's degree in Software Engineering or Electronics or, have reached this level through another form of training or experience. 3-5 years Embedded software/firmware development experience, in either the mobile industry or in semiconductors. Proud software craftsman with solid BLE 5.X experience, preferably in both Link Layer and Host stack Natural team player and obsessive to learn and gain experience Spoken and written English Knowledge of design methods and software engineering processes, Microcontroller architectures and peripherals, Embedded programming in C. Strong Python programming skills Building Real Time systems on bare metal or using an RTOS, structured debugging, interpretation of PCB schematics. Practical experience using the Scrum framework Experience in technical coaching of junior team members Additional context of the role: Idea is to find a candidate with a strong BLE knowledge. The work to be done is to develop the upper level (application level) of the BLE communication protocol stack which are not yet existing. To do this, knowledge/understanding/experience of the lower levels is absolutely necessary ( Link Layer and Host stack). The testing part of the job will be relatively limited to the beginning of the assignment. At that time 50% of the time should be spend within the R&D team which is currently struggling with the validation testing. Helping on this aspect will serve as an introduction to the product for the candidate. Finally, we want a senior profile as one of the tasks will be to lead the team in the "go to market strategy". The product till now is developed for use cases of specific customers but idea is to make it a mass product. The senior engineer should help here to identify what may be missing in the product to reach a broader audience, for example by comparison with competitors. This part will require again to interact with the R&D team.
29/04/2024
Project-based
Senior Connectivity Firmware/Test Engineer 1 year freelance contract + extensions after Leuven, Belgium (2 days remote per week) Within our Personal Health R&D group, we want to capture the strong market growth in ICs for hearing aids and implants, hearables, wearables, and personal health monitoring applications, health IoT. Owing to our success, our department of 40+ engineers is growing, and we have challenging opportunities for software engineers. Our System-on-Chip products employ the latest Bluetooth Smart (BLE) or NFC with our experience in ultra-low power design. We develop the full software stack from driver-level all to way to turnkey applications, enabling our customers to build their products with minimum effort. Description of services: Unconditionally technically responsible for a subsystem, application Estimate the effort for your work and contribute to reviewing the estimates of peers Execute feasibility studies to underpin the estimations Create a design for the software Organize or contribute to (mutual) reviews of designs with colleagues and Software Architect Plan your assignments and report on progress Contribute to specifying and developing automated regression test frameworks. Document functional and performance specifications, test design documentation and develop the test strategy and test specifications. Work with the development team to develop and guide the implementation of module, systems and end to end tests (functional + performance testing) to fit in the test framework. Develop test automations using Python, Jenkins. Experience: Master's degree in Software Engineering or Electronics or, have reached this level through another form of training or experience. 3-5 years Embedded software/firmware development experience, in either the mobile industry or in semiconductors. Proud software craftsman with solid BLE 5.X experience, preferably in both Link Layer and Host stack Natural team player and obsessive to learn and gain experience Spoken and written English Knowledge of design methods and software engineering processes, Microcontroller architectures and peripherals, Embedded programming in C. Strong Python programming skills Building Real Time systems on bare metal or using an RTOS, structured debugging, interpretation of PCB schematics. Practical experience using the Scrum framework Experience in technical coaching of junior team members Additional context of the role: Idea is to find a candidate with a strong BLE knowledge. The work to be done is to develop the upper level (application level) of the BLE communication protocol stack which are not yet existing. To do this, knowledge/understanding/experience of the lower levels is absolutely necessary ( Link Layer and Host stack). The testing part of the job will be relatively limited to the beginning of the assignment. At that time 50% of the time should be spend within the R&D team which is currently struggling with the validation testing. Helping on this aspect will serve as an introduction to the product for the candidate. Finally, we want a senior profile as one of the tasks will be to lead the team in the "go to market strategy". The product till now is developed for use cases of specific customers but idea is to make it a mass product. The senior engineer should help here to identify what may be missing in the product to reach a broader audience, for example by comparison with competitors. This part will require again to interact with the R&D team.
Plant Engineer - Facilities and Utilities vacancy for a globally operating Neuchatel based company in the pharmaceutical sector . Your tasks: Supporting the delivery of complex site-wide projects as a technical expert in plant operations and organizational boundaries Serving as the Subject Matter Expert for critical GMP utilities, including HVAC, water systems, chillers, and process gases Driving investigations, deviations, and CAPAs, maintaining strict adherence to cGMP, GEP, and EHS standards to uphold operational excellence Leading the design, qualification, and implementation of equipment and plant optimizations Monitoring and approving the implementation of supplier interventions for facility and utility equipment Facilitating cross-functional collaboration to enhance operational efficiency and technical problem-solving capabilities Your experience/knowledge: 5+ years of experience in project management in the Pharma, Biotech, Chemistry, or Energy industry Solid understanding of a GMP environment and relevant regulations Proficient in Microsoft Office Suite, including Word, Excel, Teams, Project, and OneNote Experience with PLC/Automation programming systems from Siemens, Johnson Controls, or Allen Bradley is advantageous Engineering degree in Mechanical, Automation/Technical Engineering, Biotechnology, Chemistry, or Physics Language skills: French and English - fluent in written and spoken, German would be an advantage Your soft skills: Excellent organizational and communication skills Location: Neuchatel, Switzerland Sector: Pharmaceutical Start: ASAP Duration: 24 MM+ Ref .Nr.: BH21592 Take the next step and send us your resume along with a daytime phone number where we can reach you. Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland. Ukrainian refugees are warmly welcomed, we will support you all the way. We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application. As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client.
26/04/2024
Project-based
Plant Engineer - Facilities and Utilities vacancy for a globally operating Neuchatel based company in the pharmaceutical sector . Your tasks: Supporting the delivery of complex site-wide projects as a technical expert in plant operations and organizational boundaries Serving as the Subject Matter Expert for critical GMP utilities, including HVAC, water systems, chillers, and process gases Driving investigations, deviations, and CAPAs, maintaining strict adherence to cGMP, GEP, and EHS standards to uphold operational excellence Leading the design, qualification, and implementation of equipment and plant optimizations Monitoring and approving the implementation of supplier interventions for facility and utility equipment Facilitating cross-functional collaboration to enhance operational efficiency and technical problem-solving capabilities Your experience/knowledge: 5+ years of experience in project management in the Pharma, Biotech, Chemistry, or Energy industry Solid understanding of a GMP environment and relevant regulations Proficient in Microsoft Office Suite, including Word, Excel, Teams, Project, and OneNote Experience with PLC/Automation programming systems from Siemens, Johnson Controls, or Allen Bradley is advantageous Engineering degree in Mechanical, Automation/Technical Engineering, Biotechnology, Chemistry, or Physics Language skills: French and English - fluent in written and spoken, German would be an advantage Your soft skills: Excellent organizational and communication skills Location: Neuchatel, Switzerland Sector: Pharmaceutical Start: ASAP Duration: 24 MM+ Ref .Nr.: BH21592 Take the next step and send us your resume along with a daytime phone number where we can reach you. Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland. Ukrainian refugees are warmly welcomed, we will support you all the way. We welcome applications from individuals of all genders, age groups, sexual orientations, personal expressions, ethnic backgrounds, and religious beliefs. Therefore, there is no requirement to provide gender information or a photo in your application. As per client requirements, we need information about your marital status, nationality, date of birth, and a valid Swiss work permit. For applicants with disabilities, we are happy to explore potential solutions with our end client.
Title: Senior C Engineer Location: East London - Up to 4 days a week on-site Salary: Up to £120k + Equity About the client: Founded in early 2021 the client I am representing is currently building the best AI video system on the market. Powered by the next-generation video artificial intelligence They have a range of customers and are growing rapidly with offices in America and London. The successful candidate will help them scale the systems to meet user demand and add new features. Your duties will include: Building edge applications processing vision data and communication layers for the compute-constrained edge devices. Deploying machine learning models to production. Optimizing the platform runtime for maximum performance. This is largely C++ code with parts of the pipeline running on GPU. Building observability and telemetry. Requirements and experience: 3+ years of experience writing production software in C++ and Python of experience building applications processing Real Time data and optimizing them for latency and memory. Experience using various profiling tools (eg, gdb, Nsight, Valgrind, flame graph) to optimize the code. Experience with Docker, and CI/CD pipelines. It would be great if you also have experience with one or more Edge/IoT computing (we have a fleet of deployed edge computers). infrastructure management (we use Salt). monitoring (we use Grafana). video processing & streaming (we use Gstreamer). experience interfacing ML models (we use PyTorch).
24/04/2024
Full time
Title: Senior C Engineer Location: East London - Up to 4 days a week on-site Salary: Up to £120k + Equity About the client: Founded in early 2021 the client I am representing is currently building the best AI video system on the market. Powered by the next-generation video artificial intelligence They have a range of customers and are growing rapidly with offices in America and London. The successful candidate will help them scale the systems to meet user demand and add new features. Your duties will include: Building edge applications processing vision data and communication layers for the compute-constrained edge devices. Deploying machine learning models to production. Optimizing the platform runtime for maximum performance. This is largely C++ code with parts of the pipeline running on GPU. Building observability and telemetry. Requirements and experience: 3+ years of experience writing production software in C++ and Python of experience building applications processing Real Time data and optimizing them for latency and memory. Experience using various profiling tools (eg, gdb, Nsight, Valgrind, flame graph) to optimize the code. Experience with Docker, and CI/CD pipelines. It would be great if you also have experience with one or more Edge/IoT computing (we have a fleet of deployed edge computers). infrastructure management (we use Salt). monitoring (we use Grafana). video processing & streaming (we use Gstreamer). experience interfacing ML models (we use PyTorch).
FIELD SERVICE ENGINEER Covering UK&IRE £40,000 - £50,000 + Excellent benefits Monday - Friday - door to door (44 hours) One of the UK's leading suppliers of highly complex process sterilisation and quality process equipment is now recruiting for a Field Service Engineer to join their busy and expanding field service engineering team to cover UK&IRE. As the field service engineer, you will be required to travel to customer sites in the pharmaceutical and life-sciences field, carrying out repair and maintenance on a diverse range of technologies including autoclaves/sterilisers, RO systems, steam generators etc. Key responsibilities as the Field Service Engineer: You will be required to travel across the UK and Ireland and will include nights away from home. Provide preventative maintenance, calibration and technical support, to a standard consistent with the high quality of the equipment and services the organisation supply and with the reasonable expectations of the customers. Undertake fault finding/rectification assignments as delegated by the management team Creating, preparing and managing servicing and calibration documentation as delegated by the management team Managing specific service spares Role specific administration such as reporting, expenses, and time sheets Proper management of the organisations equipment, including test equipment, computer equipment etc. Support the training of other Field Service Engineers Provide FAT support as required. Additional administrative duties as required, including but not limited to, protocol review, document creation as per QMS. Adhering to policies and procedures at all times Experience required - Field Service Engineer: ONC/HNC or equivalent in engineering (mechanical, electrical, electronic etc.) Multi-skilled engineer who has carried out service, repair and maintenance on industrial sized electro-mechanical machinery Industry background could be; FMCG, Ex-Military (Navy, REME, RAF etc.), Automation, Robotics, Pharmaceutical, Biotechnology, Semi-Conductor, Oil & Gas etc. Flexible to travel and stay away as and when required as a field service engineer Valid, UK driving licence Package/benefits: £40,000 - £50,000 depending on experience Company performance bonus Paid overtime x1.5 - Monday Friday any hours over 44 hrs (door to door travel) Overnight stay allowance - £20 for first night away raising an extra £10 per night for consecutive nights (Capped at £110/night). Once fully out on your own - Night 1-4 -£62 p/n, nights 5-7 - £80 p/n, nights 8 onwards is £100p/n. Lunch allowance Company vehicle included for personal use or the option for business use only Company Pension scheme 25 dyas holiday + bank Company phone & laptop Tools and uniform supplied Annual salary reviews (linked to inflation) plus continuously review salary in relation to performance. If you are and experienced multi-skilled field service engineer interested in making an application, please click APPLY NOW and a CBSbutler representative will be in touch to discuss this exciting opportunity.
24/04/2024
Full time
FIELD SERVICE ENGINEER Covering UK&IRE £40,000 - £50,000 + Excellent benefits Monday - Friday - door to door (44 hours) One of the UK's leading suppliers of highly complex process sterilisation and quality process equipment is now recruiting for a Field Service Engineer to join their busy and expanding field service engineering team to cover UK&IRE. As the field service engineer, you will be required to travel to customer sites in the pharmaceutical and life-sciences field, carrying out repair and maintenance on a diverse range of technologies including autoclaves/sterilisers, RO systems, steam generators etc. Key responsibilities as the Field Service Engineer: You will be required to travel across the UK and Ireland and will include nights away from home. Provide preventative maintenance, calibration and technical support, to a standard consistent with the high quality of the equipment and services the organisation supply and with the reasonable expectations of the customers. Undertake fault finding/rectification assignments as delegated by the management team Creating, preparing and managing servicing and calibration documentation as delegated by the management team Managing specific service spares Role specific administration such as reporting, expenses, and time sheets Proper management of the organisations equipment, including test equipment, computer equipment etc. Support the training of other Field Service Engineers Provide FAT support as required. Additional administrative duties as required, including but not limited to, protocol review, document creation as per QMS. Adhering to policies and procedures at all times Experience required - Field Service Engineer: ONC/HNC or equivalent in engineering (mechanical, electrical, electronic etc.) Multi-skilled engineer who has carried out service, repair and maintenance on industrial sized electro-mechanical machinery Industry background could be; FMCG, Ex-Military (Navy, REME, RAF etc.), Automation, Robotics, Pharmaceutical, Biotechnology, Semi-Conductor, Oil & Gas etc. Flexible to travel and stay away as and when required as a field service engineer Valid, UK driving licence Package/benefits: £40,000 - £50,000 depending on experience Company performance bonus Paid overtime x1.5 - Monday Friday any hours over 44 hrs (door to door travel) Overnight stay allowance - £20 for first night away raising an extra £10 per night for consecutive nights (Capped at £110/night). Once fully out on your own - Night 1-4 -£62 p/n, nights 5-7 - £80 p/n, nights 8 onwards is £100p/n. Lunch allowance Company vehicle included for personal use or the option for business use only Company Pension scheme 25 dyas holiday + bank Company phone & laptop Tools and uniform supplied Annual salary reviews (linked to inflation) plus continuously review salary in relation to performance. If you are and experienced multi-skilled field service engineer interested in making an application, please click APPLY NOW and a CBSbutler representative will be in touch to discuss this exciting opportunity.
Digital & Technology Advisory Lead) - Aero and Rail Transportation Location: UK/Europe ( Preferably: UK/France/Italy ) Remote-Flexible for travel if required Experience: 10+ years of experience in an ER&D segment, a technology leader having performed roles in Business Development, Pre-sales, Customer facing engagements, Industry expert working and living in Europe. Job Description Business Development Skills & Experience: Driving end-to-end pursuit cycle Work very closely (possibly co-located) and working closely with Sales & Account Management to identify/create, qualify and drive to closure, opportunities with medical devices and healthcare providers. Shape and solution software engagements in collaboration with subject matter experts as relevant. Develop and communicate compelling value propositions with key stakeholders (CTO/Engineering/Product Digital Org.); Client relationship management and networking with Clients R&D peers: Forging strong relationships Build trusted advisor relationships and influential partnerships with clients R&D peer architect/SMEs/specialist based on a strong foundation of business and technology expertise and leverage them to gather insights concerning eg on-going/upcoming project initiatives/WoW/technical approaches-directions at customer end Job Description Summary Lead will be responsible for supporting the go-to-market efforts of Client's Aero and Rail Transport business having worked in the industry and deep understanding of the market including trends and projects in rolling stock, rail control, services, and infrastructure. Signaling and Supervision systems, next Generation Platforms, Cybersecurity. An ideal candidate should be familiar with and having been involved with generating new business in following areas: - Digital Engineering (Digital Thread, PLM, MOM, Aftermarket sales), Digital Technology (Data Platforms, Data Analytics, GEN AI Cloud software solutions), - Autonomous Solutions (Smart Factors, Intelligent Products, hyper sensorization and IoT, V&V, H/W Build to Spec Products, and S/W Embedded solutions, Wireless Connectivity in Aero& Rail Transport), - Sustainability (Renewable materials and smart grids, renewable fuels eg, Hydrogen, Electrification and EV solutions)
23/04/2024
Full time
Digital & Technology Advisory Lead) - Aero and Rail Transportation Location: UK/Europe ( Preferably: UK/France/Italy ) Remote-Flexible for travel if required Experience: 10+ years of experience in an ER&D segment, a technology leader having performed roles in Business Development, Pre-sales, Customer facing engagements, Industry expert working and living in Europe. Job Description Business Development Skills & Experience: Driving end-to-end pursuit cycle Work very closely (possibly co-located) and working closely with Sales & Account Management to identify/create, qualify and drive to closure, opportunities with medical devices and healthcare providers. Shape and solution software engagements in collaboration with subject matter experts as relevant. Develop and communicate compelling value propositions with key stakeholders (CTO/Engineering/Product Digital Org.); Client relationship management and networking with Clients R&D peers: Forging strong relationships Build trusted advisor relationships and influential partnerships with clients R&D peer architect/SMEs/specialist based on a strong foundation of business and technology expertise and leverage them to gather insights concerning eg on-going/upcoming project initiatives/WoW/technical approaches-directions at customer end Job Description Summary Lead will be responsible for supporting the go-to-market efforts of Client's Aero and Rail Transport business having worked in the industry and deep understanding of the market including trends and projects in rolling stock, rail control, services, and infrastructure. Signaling and Supervision systems, next Generation Platforms, Cybersecurity. An ideal candidate should be familiar with and having been involved with generating new business in following areas: - Digital Engineering (Digital Thread, PLM, MOM, Aftermarket sales), Digital Technology (Data Platforms, Data Analytics, GEN AI Cloud software solutions), - Autonomous Solutions (Smart Factors, Intelligent Products, hyper sensorization and IoT, V&V, H/W Build to Spec Products, and S/W Embedded solutions, Wireless Connectivity in Aero& Rail Transport), - Sustainability (Renewable materials and smart grids, renewable fuels eg, Hydrogen, Electrification and EV solutions)
The Opportunity: We're on the lookout for an Intelligent Transport Systems (ITS)/Transport Technology Consultant to assist in the development of highways technology schemes and solutions that will shape the digital roadmap for roadside technology asset improvements and rollouts. You'll operate in a Front End Consultancy role in a client facing position, understanding and analysing their needs, challenges and goals and providing expert advice and recommendations on how to optimize and enhance current and future roadside technology solutions. This role will attract those in Front End ITS Consultancy that want greater autonomy and career opportunities. Likewise it could also suit someone with a scheme design background using motorway technology assets (CCTV/MIDAS/SVD/ERT/MS3/4) and infrastructure. Both types of profile will need exceptional communication (written and verbal) and analytical skills, who can deliver professional consultancy services. Skills and Experience: A degree or equivalent experience in a technology based engineering discipline (electronic/electrical engineering, communications, etc.) Experience of design roadside technology schemes calculations and drawings, along with the ability to communicate these in a non-technical way A broad, but in depth understanding of technology aimed at the transport/mobility sector (sensors, camera, IoT devices, V2I, etc.) Exceptional communication, client/stakeholder management and analytical abilities, with prior client facing experience into transport related public sector bodies (National Highways, TfL, TfGM, etc.) Full UK Driving Licence Please call James Sample here at ISR to learn more
23/04/2024
Full time
The Opportunity: We're on the lookout for an Intelligent Transport Systems (ITS)/Transport Technology Consultant to assist in the development of highways technology schemes and solutions that will shape the digital roadmap for roadside technology asset improvements and rollouts. You'll operate in a Front End Consultancy role in a client facing position, understanding and analysing their needs, challenges and goals and providing expert advice and recommendations on how to optimize and enhance current and future roadside technology solutions. This role will attract those in Front End ITS Consultancy that want greater autonomy and career opportunities. Likewise it could also suit someone with a scheme design background using motorway technology assets (CCTV/MIDAS/SVD/ERT/MS3/4) and infrastructure. Both types of profile will need exceptional communication (written and verbal) and analytical skills, who can deliver professional consultancy services. Skills and Experience: A degree or equivalent experience in a technology based engineering discipline (electronic/electrical engineering, communications, etc.) Experience of design roadside technology schemes calculations and drawings, along with the ability to communicate these in a non-technical way A broad, but in depth understanding of technology aimed at the transport/mobility sector (sensors, camera, IoT devices, V2I, etc.) Exceptional communication, client/stakeholder management and analytical abilities, with prior client facing experience into transport related public sector bodies (National Highways, TfL, TfGM, etc.) Full UK Driving Licence Please call James Sample here at ISR to learn more
GMP Compliance Experte (m/w/d) - Änderungsprozesse/GMP/Deutsch/Qualitätssicherung/Zulassungsbehörden Projekt: Für unseren Kunden, ein grosses Pharmaunternehmen mit Sitz in Basel suchen wir einen GMP Compliance Experte (m/w/d) Hintergrund: Als GMP Compliance Expertin/Experte im Bereich GxP Compliance Fundamentals & Technical Standards, sind Sie im Bereich Technik des Standortes Basel & Kaiseraugst tätig. Dieser ist für die Realisierung und Instandhaltung der biotechnologischen, chemischen und galenischen Produktionsanlagen der Division Pharma in den Werken Basel/Kaiseraugst zuständig. Zusätzlich ist der Bereich Technik für den GMP-konformen Betrieb der Infrastrukturanlagen und Areal Versorgungssysteme verantwortlich. Der Bereich GxP Compliance Fundamentals & Technical Standards unterstützt den Standort Technical Services/PS (Technik und Logistik am Standort Basel/Kaiseraugst) in allen cGMP-Fragestellungen und setzt sich für vorausschauende, effiziente und kontinuierlich verbesserte Prozesse entlang der Wertschöpfungskette ein. Der oder die perfekte Kandidat:in hat eine abgeschlossene technische Ausbildung oder Studium im technischen Bereich sowie mindestens 3 Jahre praktische Erfahrung im Bereich Compliance/Qualitätssicherung von pharmazeutischen, chemischen oder biotechnologischen Anlagen. Ausserdem werden mindestens 3 Jahre praktische Erfahrung in der Umsetzung von technischen GMP-Anforderungen der Zulassungsbehörden (RHI, FDA, EMA etc.) in Investitionsprojekten bzw. in der galenischen/chemischen Produktion benötigt. Hauptaufgaben und Verantwortungsbereiche: . Koordination/Implementierung und Mitarbeit bei den Abweichungs-, Change-, Risiko- und Änderungsprozessen Planned Event (PE)/Unplanned Event (UPE). . Unterstützung interner Kunden als anerkannter Berater in sämtlichen technischen GMP Fragestellungen, z.B. Dokumentation von PE/UPE. . Prozess Management System - Erstellung, Review und Update von Dokumenten. . Prüfen neuester Entwicklungen bezüglich cGMP, kontinuierliche Verbesserung der Prozesse sowie der verwendeten Systeme. Must Haves: . Abgeschlossene technische Ausbildung oder Studium im technischen Bereich . Min. 3 Jahre praktische Erfahrung im Bereich Compliance/Qualitätssicherung von pharmazeutischen, chemischen oder biotechnologischen Anlagen . Min. 3 Jahre praktische Erfahrung in der Umsetzung von technischen GMP-Anforderungen der Zulassungsbehörden (RHI, FDA, EMA etc.) in Investitionsprojekten bzw. in der galenischen/chemischen Produktion . Gute IT-Kenntnisse (z.B. Google Suite) und Affinität sich in neue Programme einzuarbeiten.* . Sehr gute Deutschkenntnisse in Wort und Schrift. Gute Englischkenntnisse von Vorteil . Teamplayer mit exzellenten Kommunikationseigenschaften und Verhandlungsfähigkeiten, gepaart mit der Fähigkeit, effektive und vertrauensvolle Beziehungen mit Kollegen und Mitarbeitenden auf verschiedenen Ebenen aufzubauen . Eigenverantwortliche und selbständige Bearbeitung komplexer Aufgaben sowie zuverlässige Durchsetzung vereinbarter Prioritäten Referenz Nr.: 923308TP Rolle: GMP Compliance Experte (m/w/d) Industrie: Pharma Arbeitsort: Basel Pensum: 80 - 100% Start: ASAP Dauer: 12 Bewerbungsfrist : 29.04.2024 Sollte diese Position Ihr Interesse geweckt haben, senden Sie uns bitte Ihr komplettes Dossier via dem Link in dieser Anzeige zu. Über uns : ITech Consult ist ein nach ISO 9001:2015 zertifiziertes Schweizer Unternehmen mit Niederlassungen in Deutschland und Irland. ITech Consult ist spezialisiert auf die Vermittlung von hochqualifizierten Kandidaten für den Personalverleih in den Bereichen, IT, Life Science & Engineering. Wir bieten Personalverleih & Payroll Dienstleistungen an. Für unsere Kandidaten ist dies kostenlos, auch bei Payroll berechnen wir Ihnen kein zusätzlichen Gebühren.
23/04/2024
Project-based
GMP Compliance Experte (m/w/d) - Änderungsprozesse/GMP/Deutsch/Qualitätssicherung/Zulassungsbehörden Projekt: Für unseren Kunden, ein grosses Pharmaunternehmen mit Sitz in Basel suchen wir einen GMP Compliance Experte (m/w/d) Hintergrund: Als GMP Compliance Expertin/Experte im Bereich GxP Compliance Fundamentals & Technical Standards, sind Sie im Bereich Technik des Standortes Basel & Kaiseraugst tätig. Dieser ist für die Realisierung und Instandhaltung der biotechnologischen, chemischen und galenischen Produktionsanlagen der Division Pharma in den Werken Basel/Kaiseraugst zuständig. Zusätzlich ist der Bereich Technik für den GMP-konformen Betrieb der Infrastrukturanlagen und Areal Versorgungssysteme verantwortlich. Der Bereich GxP Compliance Fundamentals & Technical Standards unterstützt den Standort Technical Services/PS (Technik und Logistik am Standort Basel/Kaiseraugst) in allen cGMP-Fragestellungen und setzt sich für vorausschauende, effiziente und kontinuierlich verbesserte Prozesse entlang der Wertschöpfungskette ein. Der oder die perfekte Kandidat:in hat eine abgeschlossene technische Ausbildung oder Studium im technischen Bereich sowie mindestens 3 Jahre praktische Erfahrung im Bereich Compliance/Qualitätssicherung von pharmazeutischen, chemischen oder biotechnologischen Anlagen. Ausserdem werden mindestens 3 Jahre praktische Erfahrung in der Umsetzung von technischen GMP-Anforderungen der Zulassungsbehörden (RHI, FDA, EMA etc.) in Investitionsprojekten bzw. in der galenischen/chemischen Produktion benötigt. Hauptaufgaben und Verantwortungsbereiche: . Koordination/Implementierung und Mitarbeit bei den Abweichungs-, Change-, Risiko- und Änderungsprozessen Planned Event (PE)/Unplanned Event (UPE). . Unterstützung interner Kunden als anerkannter Berater in sämtlichen technischen GMP Fragestellungen, z.B. Dokumentation von PE/UPE. . Prozess Management System - Erstellung, Review und Update von Dokumenten. . Prüfen neuester Entwicklungen bezüglich cGMP, kontinuierliche Verbesserung der Prozesse sowie der verwendeten Systeme. Must Haves: . Abgeschlossene technische Ausbildung oder Studium im technischen Bereich . Min. 3 Jahre praktische Erfahrung im Bereich Compliance/Qualitätssicherung von pharmazeutischen, chemischen oder biotechnologischen Anlagen . Min. 3 Jahre praktische Erfahrung in der Umsetzung von technischen GMP-Anforderungen der Zulassungsbehörden (RHI, FDA, EMA etc.) in Investitionsprojekten bzw. in der galenischen/chemischen Produktion . Gute IT-Kenntnisse (z.B. Google Suite) und Affinität sich in neue Programme einzuarbeiten.* . Sehr gute Deutschkenntnisse in Wort und Schrift. Gute Englischkenntnisse von Vorteil . Teamplayer mit exzellenten Kommunikationseigenschaften und Verhandlungsfähigkeiten, gepaart mit der Fähigkeit, effektive und vertrauensvolle Beziehungen mit Kollegen und Mitarbeitenden auf verschiedenen Ebenen aufzubauen . Eigenverantwortliche und selbständige Bearbeitung komplexer Aufgaben sowie zuverlässige Durchsetzung vereinbarter Prioritäten Referenz Nr.: 923308TP Rolle: GMP Compliance Experte (m/w/d) Industrie: Pharma Arbeitsort: Basel Pensum: 80 - 100% Start: ASAP Dauer: 12 Bewerbungsfrist : 29.04.2024 Sollte diese Position Ihr Interesse geweckt haben, senden Sie uns bitte Ihr komplettes Dossier via dem Link in dieser Anzeige zu. Über uns : ITech Consult ist ein nach ISO 9001:2015 zertifiziertes Schweizer Unternehmen mit Niederlassungen in Deutschland und Irland. ITech Consult ist spezialisiert auf die Vermittlung von hochqualifizierten Kandidaten für den Personalverleih in den Bereichen, IT, Life Science & Engineering. Wir bieten Personalverleih & Payroll Dienstleistungen an. Für unsere Kandidaten ist dies kostenlos, auch bei Payroll berechnen wir Ihnen kein zusätzlichen Gebühren.