Negotiable
Undetermined
Undetermined
Belgium, Brussels
Summary: The Senior C&Q Engineer role is a 6-month contract based in Brussels, Belgium, focused on supporting a global biopharmaceutical organization. The position requires extensive experience in commissioning and qualification (C&Q) processes, with responsibilities including document drafting, compliance management, and verification testing. The role offers an opportunity to advance one's career in a supportive and innovative environment. Candidates should possess a strong technical background and leadership skills to collaborate effectively with stakeholders.
Key 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.
Key Skills:
- Extensive hands-on, end to end experience with this equipment in International CAPEX C&Q.
- Technical qualification at third level or equivalent in Engineering. English is must.
- 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.
- 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 Communication/Leadership skills.
- Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
Salary (Rate): undetermined
City: Brussels
Country: Belgium
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other