Senior C&Q Engineer
4 weken geleden
To support an important project on site for a client in the pharmaceutical sector in the region of Brussels we are hiring a SENIOR C&Q ENGINEER with experience in upstream process equipment.
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 3,600 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- 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.
- 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.
- Drive verification testing, protocol execution, walk-downs, verification of system drawings, design and operational testing and troubleshoot as required. Conduct deviation investigation and resolution for problems and issues encountered during field execution activities.
- Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s).
- Take appropriate corrective actions as required to ensure deadlines and milestones are achieved.
- Accountable for the Review and acceptance by the team of turnover of equipment / system from construction group.
- Ensures Start-up of equipment/ system is completed in a safe and coordinated manner.
- Generate and or review change controls related to C&Q and drive their closure in a timely manner
- Ensures all personnel who perform C&Q activities for the system(s) have relevant training assigned.
- Assist/ facilitate in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Systems in scope.
- 5+ years of hands-on, end to end experience with this equipment in International CAPEX C&Q .
- Technical qualification at third level or equivalent in Engineering.
- Extensive knowledge and demonstrated experience delivering Commissioning and Qualification for Pharmaceutical / Biotechnology projects including automation related aspects of equipment.
- Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry.
- Experience with ISPE best practice / GAMP-5/ Anex 15 GMP EU/ ASTM E2500/ electronic execution.
- Experience with Post OQ activities is preferred.
- Experience of sterile / biotech / single use equipment in the bio-pharmaceutical industry is preferred.
- Knowledge of safety, GMP and environmental regulatory requirements.
- Ability to make decision under pressure and demonstrated strong Analytical/ Communication/ Leadership skills.
- Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
- English is a must, knowledge of French is an advantage.
Why PM Group?
As an employee-owned company, we are inclusive, committed and driven. Corporate Responsibility and Sustainability are the heart of our new 2025 business strategy. Click HERE to read more in our 'Corporate Responsibility and Health, Safety and Wellbeing Report'.
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