Commissioning Qualification Technical Lead

 ​ For Commissioning & Qualification support in the Engineering area. 

WHAT MAKES YOU A FIT: 
The Technical Part:

• Bachelor’s Degree in Life Science or Engineering, and previous years of exposure in Validation Life Cycle and Packaging activities within the Pharmaceutical Industry.
• Languages: English - fluent in speaking and writing.
• Shift: Administrative, and according to business needs.
• Experience in:
• Leadership and management roles.
• Process Commissioning and Qualification. 
• Engineering disciplines, commissioning, compliance, qualification, and quality aspects of biopharma or pharmaceutical manufacturing.

• Being self-motivated means that you are curious, anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you’re creative, with such an eye for detail that nothing gets past you. If this sounds like you, and if you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!

• Responsible for planning, preparation, coordination and leading a CQ team from documentation preparation through Design, FAT, CM oversight, MC, integrated CQ execution and successful handover to the Client USER team.
• The CQ SME will lead and coordinate a CQV team that consists of CQV leads/specialists, engineers, operations personnel, engineering and external vendors, contractors, sub-contractors including the automation integrator and CSV service provider.
• Ensure that overall Budget, Baseline Schedule, Compliance, Quality and HSE objectives are achieved in line with Project expectations. The CQ Lead will form part of the Client leadership team attending core team meetings, providing guidance on CQ matters and representing PDP in terms or contractual obligations.
• Development of an overall level 3 CQ plan in conjunction with the Client project scheduler.Meeting and delivering key project milestones.
• Lead various weekly multidisciplinary CQV, Eng, CM and USER coordination meetings. Org chart maintenance and resourcing.
• HSE and Safe Start-Up including LOTO. CQV Doc Preparation. CQV Execution Readiness. CQV Execution. P+ID Walk down and Punch item Categorization.
• Deviation Management & Change Control (Process and Automation). Punch List Management Vendor Management.
• Developing and Reviewing CQ test plans and specifications prior to their approvals.
• Development and maintenance of training material, matrix and files for all those involved in CQV activities (Integrator, CSV provider, Vendors, Client USERs).
• Management and Filing of CQV related documentation.
• Management: Compliance with a schedule at a system and area level with the planned resource levels.

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