About Us We are the International Division of our client, quoted on the LSE. Our client provides innovative and high-quality engineered components for the fenestration industry. The Division operates in Europe, Africa, Asia, Australia and Latin America. It is headquartered in Bologna and besides in Italy, it has manufacturing operations in the UK, China and Australia, along with sales and distribution units with light assembly facilities in Argentina, France, Greece, India, Spain, Turkey, Brasil, Germany and the United Arab Emirates. Our client's products are sold into residential and commercial applications all over the world under the Schlegel brand for sealing solutions to aluminium, PVCu and timber applications, the Giesse brand for hardware systems in aluminium doors and windows and the Reguitti brand for doors and windows handles. What You'll Do For our plant located in Henlow, we are looking for a Maintenance Engineer to join our team. Your main tasks & responsibilities Maintain and service all production machinery, using a multi-skilled approach, in accordance with manufacturers OEM'S Provide frontline engineering support Assist the Engineering Supervisor in minimising machine down time by proposing and introducing improved maintenance programmes and continuous improvement ideas Execute DPM/PPM systems Carry out property/facility maintenance duties as required Carry out routine statutory checks as required Complete a breakdown/fault log on a daily basis Liaise with the cell leaders on a daily basis providing engineering support Liaise with contracted service providers when on site, sign on/off in line with the companies site visitor/"permit to work" procedures Ensure TDI Monitoring system is operating correctly at all times Monitor engineering stock usage, order spares as required to provide continuous production support Participate in continuous improvement programmes Complete additional skills training as required by the company To provide out of hours "call-out" service Carry out such other duties as the management team may reasonably require To adhere to all Health, Safety and Environmental procedures To report any unsafe acts or Health, Safety and Environmental incidents Key Contacts Engineering Manager Engineering Supervisor Plant Manager Production Manager Shift Supervisors Key Outputs Contribute to smooth operation of production plant and site facilities. Key Skills Ideally Electrically Biased Multi Skilled Apprenticeship and NVQ level 3 Electrical 18th Edition qualification desirable Technically competent Knowledge of electrical/mechanical DPM/PPM procedures an advantage Knowledge of hydraulic and pneumatic systems an advantage Conversant with electrical/PLC control systems desirable Conversant with H&S rules, regulations and best practices (LOTO) Ability to prioritise workload and concisely record information Basic IT Knowledge Be able to work independently and part of a team "Hands on" and "can do" approach Additional Information Competitive Salary Immediate start
16/05/2024
Full time
About Us We are the International Division of our client, quoted on the LSE. Our client provides innovative and high-quality engineered components for the fenestration industry. The Division operates in Europe, Africa, Asia, Australia and Latin America. It is headquartered in Bologna and besides in Italy, it has manufacturing operations in the UK, China and Australia, along with sales and distribution units with light assembly facilities in Argentina, France, Greece, India, Spain, Turkey, Brasil, Germany and the United Arab Emirates. Our client's products are sold into residential and commercial applications all over the world under the Schlegel brand for sealing solutions to aluminium, PVCu and timber applications, the Giesse brand for hardware systems in aluminium doors and windows and the Reguitti brand for doors and windows handles. What You'll Do For our plant located in Henlow, we are looking for a Maintenance Engineer to join our team. Your main tasks & responsibilities Maintain and service all production machinery, using a multi-skilled approach, in accordance with manufacturers OEM'S Provide frontline engineering support Assist the Engineering Supervisor in minimising machine down time by proposing and introducing improved maintenance programmes and continuous improvement ideas Execute DPM/PPM systems Carry out property/facility maintenance duties as required Carry out routine statutory checks as required Complete a breakdown/fault log on a daily basis Liaise with the cell leaders on a daily basis providing engineering support Liaise with contracted service providers when on site, sign on/off in line with the companies site visitor/"permit to work" procedures Ensure TDI Monitoring system is operating correctly at all times Monitor engineering stock usage, order spares as required to provide continuous production support Participate in continuous improvement programmes Complete additional skills training as required by the company To provide out of hours "call-out" service Carry out such other duties as the management team may reasonably require To adhere to all Health, Safety and Environmental procedures To report any unsafe acts or Health, Safety and Environmental incidents Key Contacts Engineering Manager Engineering Supervisor Plant Manager Production Manager Shift Supervisors Key Outputs Contribute to smooth operation of production plant and site facilities. Key Skills Ideally Electrically Biased Multi Skilled Apprenticeship and NVQ level 3 Electrical 18th Edition qualification desirable Technically competent Knowledge of electrical/mechanical DPM/PPM procedures an advantage Knowledge of hydraulic and pneumatic systems an advantage Conversant with electrical/PLC control systems desirable Conversant with H&S rules, regulations and best practices (LOTO) Ability to prioritise workload and concisely record information Basic IT Knowledge Be able to work independently and part of a team "Hands on" and "can do" approach Additional Information Competitive Salary Immediate start
QA Engineer - Validation Expert vacancy for a globally operating Neuchatel based company in the pharmaceutical sector . Your tasks: Reviewing deviations in engineering events within quality systems to ensure compliance with standard procedures and regulatory requirements Overseeing and approving engineering-controlled documentation revisions and requalifications of cleaning/sterilization processes Performing assessments of change control from a Quality Engineering standpoint Attending all meetings relevant to quality engineering tasks and respecting the escalation process Ensuring completion of relevant training and managing software access according to company policies Supporting occasional quality oversight tasks, such as continuous improvement initiatives and GMP tours of technical areas Your experience/knowledge: 2+ years of operational cGMP experience in a Quality Ops or Engineering department at a Manufacturing site in the Pharmaceuticals, Biotech or Sterile Injectables industry Knowledge of Quality standards and Quality Systems like Deviations, CAPA, Change Control, Training, Documentation Technical knowledge of maintenance, facilities, utilities, HVAC, calibration would be a plus Proficiency with Microsoft pack Technical and scientific academic training Language skills: French and English - fluent in written and spoken Your soft skills: Strong collaboration and teamwork skills Agility and autonomy Location: Neuchatel, Switzerland Sector: Pharmaceutical Start: ASAP Duration: 08MM+ Ref .Nr.: BH21646 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.
14/05/2024
Project-based
QA Engineer - Validation Expert vacancy for a globally operating Neuchatel based company in the pharmaceutical sector . Your tasks: Reviewing deviations in engineering events within quality systems to ensure compliance with standard procedures and regulatory requirements Overseeing and approving engineering-controlled documentation revisions and requalifications of cleaning/sterilization processes Performing assessments of change control from a Quality Engineering standpoint Attending all meetings relevant to quality engineering tasks and respecting the escalation process Ensuring completion of relevant training and managing software access according to company policies Supporting occasional quality oversight tasks, such as continuous improvement initiatives and GMP tours of technical areas Your experience/knowledge: 2+ years of operational cGMP experience in a Quality Ops or Engineering department at a Manufacturing site in the Pharmaceuticals, Biotech or Sterile Injectables industry Knowledge of Quality standards and Quality Systems like Deviations, CAPA, Change Control, Training, Documentation Technical knowledge of maintenance, facilities, utilities, HVAC, calibration would be a plus Proficiency with Microsoft pack Technical and scientific academic training Language skills: French and English - fluent in written and spoken Your soft skills: Strong collaboration and teamwork skills Agility and autonomy Location: Neuchatel, Switzerland Sector: Pharmaceutical Start: ASAP Duration: 08MM+ Ref .Nr.: BH21646 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.
Mes Author to work for a Pharmaceutical company The role is as follows Mes Author role Remote - There is a chance of 2 weeks onsite anywhere in the world (this will be fully expensed) Outside ir35 Rate - TBC 1 stage interview process next week Start - Late June/Early July 6 months contract Purpose: -To maintain the POMSnet environment; to author & maintain recipes & worksheets for API & DP manufacturing; and also author and maintain the recipes & BOMs in SAP. - To operate as a team member within the MES team in the implementation and maintenance of the MES & SAP system for the API & DP buildings. Responsibilities: Liaise with Manufacturing and Quality to close out MES execution exceptions. Troubleshoot and provide solutions for all MES & SAP problems in recipe execution and recipe authoring. Liaise with quality to provide approved documentation for all MES system changes. Design, create, write and execute system and test documentation to a high quality standard. Design, create, write and/or make all required changes to MES & SAP Recipes, worksheets, equipment and material spec's including phase transition logic to a high quality standard. Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures (CIs, CIRs, MIs, MIRs and SOPs) are aligned to MES processes and vice versa. Design, create, write and provide training for all other site personnel on their related MES roles. Participate in MES knowledge exchanges, MES Governance meetings, GMES Technical Review Board (TRB) Meetings, and manage issues, work-around and fixes identified. Work closely with IT regarding upgrades, patching, hardware support, security and system access. Liaise with GMES on Sligo required system improvements. Provide support to other MES system users as required to ensure business continuity. Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration. Keep other recipe authors up to date on MES changes. Documentation of all activities in line with cGMP requirements. Cross training within the team and training of new team members. Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems. Adheres to and supports all EHS & E standards, procedures and policies. Supervision Received -The position will report directly to the Global process owner, - Goals are reviewed on a regular basis and formal performance reviews are carried out once per year. Supervision Provided - No direct reports. - Maintains regular contact with support functions on site. Qualifications: Diploma qualification in suitable science/engineering course and/or suitable experience. Job/Technical Skills A minimum of 5 years' experience in Batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required. Experience in the operating in a highly automated environment and safe handling of dangerous chemicals is required for this role. A good knowledge of IT systems/MES is required for this role. Cognitive/Business Skills The position requires a high level of attention to detail and mental concentration, to ensure total compliance with procedures at all times. The position requires proven problem solving skills, and the ability to adapt to new manufacturing process on a regular basis. The position requires proven technical skills, to ensure the person can cope with the technical demands of the position at all times. Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis. Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders. Requires total commitment to quality and maintaining a high standard of work at all times. Demonstrates the highest levels of integrity and a strong work ethic at all times. Strong communication skills both verbal and written are required for the execution of this role. Strong interpersonal skills are required. Understands and Supports the principles of Perfect Performance. Ownership/Accountability This position is responsible for ensuring the smooth running of the MES system and ensuring availability to manufacturing at all times. The position has a high level of autonomy and individuals are expected to work on their own initiative. Shows a high level of tenacity to ensure closure of issues. This position is crucial in maintaining the compliance of validated systems ensuring that any changes or modifications are documented and actioned. Demonstrates an ethos of Right First Time at all times. Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines.
13/05/2024
Project-based
Mes Author to work for a Pharmaceutical company The role is as follows Mes Author role Remote - There is a chance of 2 weeks onsite anywhere in the world (this will be fully expensed) Outside ir35 Rate - TBC 1 stage interview process next week Start - Late June/Early July 6 months contract Purpose: -To maintain the POMSnet environment; to author & maintain recipes & worksheets for API & DP manufacturing; and also author and maintain the recipes & BOMs in SAP. - To operate as a team member within the MES team in the implementation and maintenance of the MES & SAP system for the API & DP buildings. Responsibilities: Liaise with Manufacturing and Quality to close out MES execution exceptions. Troubleshoot and provide solutions for all MES & SAP problems in recipe execution and recipe authoring. Liaise with quality to provide approved documentation for all MES system changes. Design, create, write and execute system and test documentation to a high quality standard. Design, create, write and/or make all required changes to MES & SAP Recipes, worksheets, equipment and material spec's including phase transition logic to a high quality standard. Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures (CIs, CIRs, MIs, MIRs and SOPs) are aligned to MES processes and vice versa. Design, create, write and provide training for all other site personnel on their related MES roles. Participate in MES knowledge exchanges, MES Governance meetings, GMES Technical Review Board (TRB) Meetings, and manage issues, work-around and fixes identified. Work closely with IT regarding upgrades, patching, hardware support, security and system access. Liaise with GMES on Sligo required system improvements. Provide support to other MES system users as required to ensure business continuity. Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration. Keep other recipe authors up to date on MES changes. Documentation of all activities in line with cGMP requirements. Cross training within the team and training of new team members. Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems. Adheres to and supports all EHS & E standards, procedures and policies. Supervision Received -The position will report directly to the Global process owner, - Goals are reviewed on a regular basis and formal performance reviews are carried out once per year. Supervision Provided - No direct reports. - Maintains regular contact with support functions on site. Qualifications: Diploma qualification in suitable science/engineering course and/or suitable experience. Job/Technical Skills A minimum of 5 years' experience in Batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required. Experience in the operating in a highly automated environment and safe handling of dangerous chemicals is required for this role. A good knowledge of IT systems/MES is required for this role. Cognitive/Business Skills The position requires a high level of attention to detail and mental concentration, to ensure total compliance with procedures at all times. The position requires proven problem solving skills, and the ability to adapt to new manufacturing process on a regular basis. The position requires proven technical skills, to ensure the person can cope with the technical demands of the position at all times. Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis. Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders. Requires total commitment to quality and maintaining a high standard of work at all times. Demonstrates the highest levels of integrity and a strong work ethic at all times. Strong communication skills both verbal and written are required for the execution of this role. Strong interpersonal skills are required. Understands and Supports the principles of Perfect Performance. Ownership/Accountability This position is responsible for ensuring the smooth running of the MES system and ensuring availability to manufacturing at all times. The position has a high level of autonomy and individuals are expected to work on their own initiative. Shows a high level of tenacity to ensure closure of issues. This position is crucial in maintaining the compliance of validated systems ensuring that any changes or modifications are documented and actioned. Demonstrates an ethos of Right First Time at all times. Adheres to and follows all procedures policies and guidelines ensuring compliance with cGMP and HPRA/FDA regulations and company policies, procedures and guidelines.