Overview
We urgently wish to recruit a C&Q Lead / Manager to support an onsite project for a client in the region of Brussels.
PM Group is a leading International engineering, architecture, project and construction management firm. With a network of offices in Europe, Asia and the US and a multi-discipline team of more than 3,700 people, we deliver complex, capital projects in the life sciences, food and beverages, mission critical/ICT, advanced manufacturing, energy and environmental sectors.
Our Vision is to be a highly valued and creative delivery partner, building a more sustainable world with our clients.
Our OTS (Outsourced Technical Services) department supports projects in different sectors on basis of project staffing with consultants working at the client’s site.
Responsibilities
Responsibilities:
As Commissioning and Qualification (C&Q) lead/ manager for Drug Substance process equipment,
and as part of an integrated team, you will act as lead for client's CQV providing expertise and Lead the
C&Q portion of the project to ensure the C&Q activities are completed safely, as per schedule and in
compliance with the system Requirements, Specifications and project procedures/ guidelines. KPI
reporting.
1. Accountable for the team drafting or support the document drafting by a partner or supplier, coordinate review and approval of applicable C&Q documents (QRA/DV/RTM/FAT/SAT/IOV/VSR) following approved VMP and SLIA.
2. Drive verification testing, protocol execution, walk-downs, verification of system drawings, design and operational testing and troubleshoot as required.
3. Conduct deviation investigation and resolution for problems and issues encountered during field execution activities.
4. Act as C&Q Subject Matter Expert and Compliance. Ability to provide guidance/ manage supplier and all C&Q activities for the system(s), from design to field execution and to summary report approval.
5. Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s).
6. Take appropriate corrective actions as required to ensure deadlines and milestones are achieved.
7. Accountable for the Review and acceptance by the team of turnover of equipment / system from construction group.
8. Ensures Start-up of equipment/ system is completed in a safe and coordinates manner.
9. Generate and or review change controls related to C&Q and drive their closure in a timely manner
10. Ensures all personnel who perform C&Q activities for the system(s) have relevant training assigned.
11. Assist/ facilitate in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Systems in scope.
Qualifications
Requirements:
12. 5+ years of hands-on, end to end experience with this equipment in International CAPEX C&Q.
13. Technical qualification at third level or equivalent in Engineering.
14. good knowledge of English is a must. (French is optional)
15. Extensive knowledge and demonstrated experience delivering Commissioning and Qualification for Pharmaceutical / Biotechnology projects including automation related aspects of equipment.
16. Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry.
17. Experience with ISPE best practice / GAMP-5/ Anex 15 GMP EU/ ASTM E2500/ electronic execution.
18. Experience with Post OQ activities is preferred.
19. Experience of sterile / biotech / single use equipment in the bio-pharmaceutical industry is preferred.
20. Knowledge of safety, GMP and environmental regulatory requirements.
21. Ability to make decision under pressure and demonstrated strong Analytical/ Communication/ Leadership skills.
22. Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.