Manufacturing Team Member- Ethicon Biosurgery-00000IRE
Description
Position Title: Manufacturing Team Member
Department: Operations
Report to: Manufacturing Team Lead
Location: Limerick
Travel: ~10% (~25% in initial 6 months)
Global Compensation Framework Band Number: 20-22
Company Summary:
Ethicon Biosurgery leverages unique technology platforms and hybrid capabilities to deliver a range of best in class products to stop bleeding, seal leaks, join structures and enhance healing. At our Limerick facility we will manufacture the Fibrin Sealant Patch. Excessive bleeding during surgical procedures is a serious and challenging problem. Currently available treatment options in these settings are not always satisfactory and so surgeons are looking for a safe and effective alternative. This product is aimed at meeting this significant unmet need. It is a truly transformational product for the management of bleeding during open procedures
Position Summary:
Manufacturing team member responsible for performing day-to-day activities within the Operations department at the Ethicon Limerick facility.
Main duties and responsibilities:
General Activities
- Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
- Working assigned shift patterns to meet business needs and operations schedule.
- Assembly and Disassembly of processing equipment
- Integrity testing of filters
- Sampling of product streams, clean utilities and performance of environmental monitoring (routine and batch specific) according to site procedures.
- Autoclaving of processing equipment
- Cleaning and sanitization of Operations facility
- Support of Commissioning and Qualification activities
- HFE Preparation, filtration and storage.
- Assembly and disassembly of Operations equipment
- Use of MES and PLC control systems to execute processing steps.
- Employ appropriate cleanroom technique to all process related activities
- Performance monitoring and appropriate action response throughout processing
- Perform Line Clearances and segregation of product
- Completion of Batch Record
- Materials Handling in the production areas
- Deputize for warehouse team members as required
- Assembly and disassembly of operations equipment for cleaning and sanitization
- Operation of washers and autoclaves to clean and sanitize equipment
- Preparation of sanitization solutions
- Ensure the workstations are maintained in excellent operational condition
- Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures. Commit to and demonstrate safe behavior in every activity.
- Carry out routine and non-routine tasks delegated by Manufacturing Team Lead according to appropriate procedures, values and standards.
- Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
- Report deviations promptly to the Team Lead to ensure compliance with EHS and GMP requirements.
- Generation of manufacturing documentation in compliance with site procedures and GDP
- Completion of all documentation in compliance with site procedures and GDP.
- Completion of transactions on ERP/MES, and other systems.
- Awareness of and adherence to good cleanroom techniques at all times.
- Ensure Operations areas are appropriately set-up to complete process steps.
- Execution Operations activities as necessary to meet operational and business needs.
- Integrity testing of equipment.
- Performance of in process testing to support batch manufacture.
- Ensure that housekeeping standards in Operations facility are maintained to a very high standard of GMP readiness.
- Segregation, processing and staging of Operations waste for off-site disposal.
- Support investigation and resolution of problems on plant.
- Participate in Cross-Functional teams as necessary.
- Participate in Emergency Response/Fire/First Aid teams as necessary.
- Assist with generation, review and revision of Operations documentation as necessary.
- Deputize for line facilitator as & when required.
- Ensure that personal training requirements are completed in compliance with site procedures.
- Develop as SMT in assigned areas and roll out training as required.
- Support and provide help to other shift team members to ensure that shift targets are met.
- Carry out routine and non-routine tasks as required, according to appropriate procedures, values and standards.
Qualifications
EDUCATION and/or EXPERIENCE:
• 1+ years experience working in a highly regulated GMP Cleanroom environment is essential.
• 1+ year experience in an automated manufacturing environment is essential.
• Leaving Certificate or equivalent/similar qualification is essential.
• Experience of Microsoft Word, Excel and Outlook is essential.
• Experience in generating cGMP documentation is desirable.
• Experience in delivering training is desirable.
• Scientific or Technical Third Level Qualification is desirable.
• Experience of MES, SCADA and PLC systems is desirable.
OTHER SKILLS and ABILITIES:
• Highly adaptable and flexible – ability to work in both highly manual packaging operations & in highly automated operations interchangably
• Strong level of attention to detail.
• Highly compliant & standard practice orientated
• Results and performance driven.
• Good interpersonal skills.
• Mechanical/Technical aptitude.
Primary Location:Europe/Middle East/Africa-Ireland-Limerick-Limerick
Organization: Johnson & Johnson Vision Care (Ireland) Limited (8182)
Job Function: Production
Description
Position Title: Manufacturing Team Member
Department: Operations
Report to: Manufacturing Team Lead
Location: Limerick
Travel: ~10% (~25% in initial 6 months)
Global Compensation Framework Band Number: 20-22
Company Summary:
Ethicon Biosurgery leverages unique technology platforms and hybrid capabilities to deliver a range of best in class products to stop bleeding, seal leaks, join structures and enhance healing. At our Limerick facility we will manufacture the Fibrin Sealant Patch. Excessive bleeding during surgical procedures is a serious and challenging problem. Currently available treatment options in these settings are not always satisfactory and so surgeons are looking for a safe and effective alternative. This product is aimed at meeting this significant unmet need. It is a truly transformational product for the management of bleeding during open procedures
Position Summary:
Manufacturing team member responsible for performing day-to-day activities within the Operations department at the Ethicon Limerick facility.
Main duties and responsibilities:
General Activities
- Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
- Working assigned shift patterns to meet business needs and operations schedule.
- Assembly and Disassembly of processing equipment
- Integrity testing of filters
- Sampling of product streams, clean utilities and performance of environmental monitoring (routine and batch specific) according to site procedures.
- Autoclaving of processing equipment
- Cleaning and sanitization of Operations facility
- Support of Commissioning and Qualification activities
- HFE Preparation, filtration and storage.
- Assembly and disassembly of Operations equipment
- Use of MES and PLC control systems to execute processing steps.
- Employ appropriate cleanroom technique to all process related activities
- Performance monitoring and appropriate action response throughout processing
- Perform Line Clearances and segregation of product
- Completion of Batch Record
- Materials Handling in the production areas
- Deputize for warehouse team members as required
- Assembly and disassembly of operations equipment for cleaning and sanitization
- Operation of washers and autoclaves to clean and sanitize equipment
- Preparation of sanitization solutions
- Ensure the workstations are maintained in excellent operational condition
- Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures. Commit to and demonstrate safe behavior in every activity.
- Carry out routine and non-routine tasks delegated by Manufacturing Team Lead according to appropriate procedures, values and standards.
- Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
- Report deviations promptly to the Team Lead to ensure compliance with EHS and GMP requirements.
- Generation of manufacturing documentation in compliance with site procedures and GDP
- Completion of all documentation in compliance with site procedures and GDP.
- Completion of transactions on ERP/MES, and other systems.
- Awareness of and adherence to good cleanroom techniques at all times.
- Ensure Operations areas are appropriately set-up to complete process steps.
- Execution Operations activities as necessary to meet operational and business needs.
- Integrity testing of equipment.
- Performance of in process testing to support batch manufacture.
- Ensure that housekeeping standards in Operations facility are maintained to a very high standard of GMP readiness.
- Segregation, processing and staging of Operations waste for off-site disposal.
- Support investigation and resolution of problems on plant.
- Participate in Cross-Functional teams as necessary.
- Participate in Emergency Response/Fire/First Aid teams as necessary.
- Assist with generation, review and revision of Operations documentation as necessary.
- Deputize for line facilitator as & when required.
- Ensure that personal training requirements are completed in compliance with site procedures.
- Develop as SMT in assigned areas and roll out training as required.
- Support and provide help to other shift team members to ensure that shift targets are met.
- Carry out routine and non-routine tasks as required, according to appropriate procedures, values and standards.
Qualifications
EDUCATION and/or EXPERIENCE:
• 1+ years experience working in a highly regulated GMP Cleanroom environment is essential.
• 1+ year experience in an automated manufacturing environment is essential.
• Leaving Certificate or equivalent/similar qualification is essential.
• Experience of Microsoft Word, Excel and Outlook is essential.
• Experience in generating cGMP documentation is desirable.
• Experience in delivering training is desirable.
• Scientific or Technical Third Level Qualification is desirable.
• Experience of MES, SCADA and PLC systems is desirable.
OTHER SKILLS and ABILITIES:
• Highly adaptable and flexible – ability to work in both highly manual packaging operations & in highly automated operations interchangably
• Strong level of attention to detail.
• Highly compliant & standard practice orientated
• Results and performance driven.
• Good interpersonal skills.
• Mechanical/Technical aptitude.
Primary Location:Europe/Middle East/Africa-Ireland-Limerick-Limerick
Organization: Johnson & Johnson Vision Care (Ireland) Limited (8182)
Job Function: Production