The Manufacturing Team Lead is responsible for start-up and on-going co-ordination of day-to-day activities of the employees within the Operations Department. This includes leadership of the operations shifts to ensure that shift targets are met. Also responsible for manufacturing processes for new products/processes working with cross-functional teams including: R&D, FOD, Quality Engineering, Clinical Teams, Analytical Labs, Procurement and Environmental/Safety. This person will be the process owner once the operation is manufacturing saleable product.
Role & Responsibilities:
Operational readiness of the manufacturing areas and processes
Support technology transfer
All activities, i.e. manufacturing, cleaning and maintenance of the manufacturing areas, equipment and processes
Implementing and maintaining appropriate and adequate EHS controls in all production areas
Assigned shift performance & resource management of production shift team
Employ strict applicable cleanroom techniques to all process related activities
Support of Commissioning and Qualification activities
Accountable for Production Batch Manufacture and Review
Ensure process equipment maintenance, calibration and repair to ensure the least amount of downtime of production lines.
Ensure compliance with all regulatory requirements particularly in relation to the pharmaceutical industry, health and safety requirements and environmental legislation and cGMP requirements
Participate in regulatory audits and ensure audit readiness at all times
Generation, review and revision of Operations documentation as necessary
Training of manufacturing team and ensure compliance with company standards
Maintains time and attendance (T&A) records for the manufacturing team
Implementing and maintenance of material, production and personnel controls
Ensuring completion of all manufacturing documentation in compliance with site procedures and GDP
Completion of transactions on ERP/MES, and other systems
Lead investigations and resolution of problems during manufacture
Key Skills and Competencies required:
Degree preferably in Biotechnology, Science or Engineering.
5+ years management/supervisory experience required, of which
2+ years management experience in an automated manufacturing environment including maintenance responsibility
2+ years of which in a aseptic (i.e. Grade B or higher) regulated manufacturing environment
Experience of autoclave, parts washer and filtration processes
Experience of ERP, MES, SCADA and PLC systemsImage may be NSFW.
Clik here to view.
Role & Responsibilities:
Operational readiness of the manufacturing areas and processes
Support technology transfer
All activities, i.e. manufacturing, cleaning and maintenance of the manufacturing areas, equipment and processes
Implementing and maintaining appropriate and adequate EHS controls in all production areas
Assigned shift performance & resource management of production shift team
Employ strict applicable cleanroom techniques to all process related activities
Support of Commissioning and Qualification activities
Accountable for Production Batch Manufacture and Review
Ensure process equipment maintenance, calibration and repair to ensure the least amount of downtime of production lines.
Ensure compliance with all regulatory requirements particularly in relation to the pharmaceutical industry, health and safety requirements and environmental legislation and cGMP requirements
Participate in regulatory audits and ensure audit readiness at all times
Generation, review and revision of Operations documentation as necessary
Training of manufacturing team and ensure compliance with company standards
Maintains time and attendance (T&A) records for the manufacturing team
Implementing and maintenance of material, production and personnel controls
Ensuring completion of all manufacturing documentation in compliance with site procedures and GDP
Completion of transactions on ERP/MES, and other systems
Lead investigations and resolution of problems during manufacture
Key Skills and Competencies required:
Degree preferably in Biotechnology, Science or Engineering.
5+ years management/supervisory experience required, of which
2+ years management experience in an automated manufacturing environment including maintenance responsibility
2+ years of which in a aseptic (i.e. Grade B or higher) regulated manufacturing environment
Experience of autoclave, parts washer and filtration processes
Experience of ERP, MES, SCADA and PLC systemsImage may be NSFW.
Clik here to view.
