PharmEng is looking for a detail-oriented and results-driven Senior CQV - Project Management for a project in Toulouse, France, to play a key role in ensuring the successful commissioning, qualification, and validation of Solid Dose Manufacturing equipment and building expansion including WIP skids, AHUs and dust collectors and other miscellaneous equipment associated with Solid Dose Manufacturing.

As a Senior CQV - Project Manager, you will be responsible for overseeing and managing the projects in the pharmaceutical manufacturing facilities and utilities. Your role will involve project planning, compliance, facility design, stakeholder coordination, quality assurance, risk management, and documentation/reporting.

Fluent French is mandatory and English is a plus.

Key Responsibilities:

1. Project Planning and Management:

1. • Develop project plans, schedules, and budgets for facility design and construction.
   • Define project scope, objectives, and deliverables in alignment with Annex 1 requirements and client expectations.
   • Coordinate resources, including personnel, equipment, and materials, to ensure efficient project execution.
   • Monitor project progress, identify risks or delays, and implement mitigation strategies.

2. Annex 1 Compliance:

2. • Apply expert knowledge of Annex 1 guidelines to ensure regulatory standards are met.
   • Collaborate with regulatory affairs and quality assurance teams to implement Annex 1 requirements.
   • Conduct regular reviews and audits to verify compliance throughout the project lifecycle.

3. Commissioning:

3. • Collaborate with engineering teams to plan and execute commissioning activities.
   • Develop commissioning plans, protocols, and reports associated with production equipment and room qualifications
   • Perform equipment and system checks to ensure functionality.
   • Troubleshoot and resolve commissioning issues promptly.

4. Qualification & Validation:

4. • Create qualification protocols and test plans for equipment, systems, and processes.
   • Execute qualification activities, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
   • Document and analyse qualification test results.
   • Identify and address any deviations from established specifications.
   • Collaborate with cross-functional teams to address and resolve validation discrepancies.
   • Develop and execute validation protocols for processes and systems.
   • Ensure validation activities are compliant with industry standards and regulatory requirements.
   • Maintain and manage validation documentation and records.
   • Complete Summary Reports to finalize the qualification of equipment and rooms.

5. Facility and Utility Design:

5. • Lead the design process for manufacturing facilities, cleanrooms, HVAC systems, and utilities.
   • Work with architects, engineers, and consultants to develop detailed facility layouts and equipment specifications.
   • Incorporate best practices in contamination control and operational efficiency.

6. Stakeholder Coordination:

6. • Serve as the primary point of contact for clients, contractors, regulatory agencies, and stakeholders.
   • Facilitate communication and collaboration among multidisciplinary teams to achieve project goals.

7. Quality Assurance:

7. • Implement quality assurance measures and develop validation protocols for facility designs.

8. Risk Management:

8. • Identify project risks and develop mitigation plans to minimize disruptions.
   • Ensure compliance with regulatory requirements throughout the project lifecycle.

9. Documentation and Reporting:

9. • Maintain accurate project documentation, including design documents and change orders.
   • Prepare progress reports and presentations for internal and external stakeholders.

• Bachelor's or Master's degree in Engineering (mechanical, chemical, biomedical) or related field.
• Fluent French is mandatory.
• Fluent English is a plus.
• Extensive experience in CQV within pharmaceutical manufacturing.
• In-depth knowledge of Annex 1 guidelines and regulatory requirements.
• Technical expertise in facility design, HVAC systems, cleanrooms, and utilities.
• Strong leadership, communication, and interpersonal skills.
• Detail-oriented with a focus on quality and compliance.