Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.
Due to our continuous growth, PQE Group is seeking a Senior C&Q Consultant to join our team in UK. We are seeking a highly motivated and experienced Senior C&Q Engineer to join our dynamic Field Services team. This is a travel-centric, employee-only role designed for a professional who thrives in a project-based environment. You will be responsible for the planning, execution, and management of commissioning and qualification activities for GxP-regulated facilities (Pharma, Biotech, and Medical Devices).
Responsibilities include, but are not limited to:
- Project Execution: Lead and execute C&Q strategies for process equipment, utilities (WFI, Clean Steam, HVAC), and automation systems in accordance with cGMP and FDA/EMA regulations.
- Documentation: Author, review, and execute Validation Protocols (IQ, OQ, PQ), FAT/SAT, and Risk Assessments.
- Troubleshooting: Provide technical troubleshooting expertise during the commissioning phase to resolve system deviations and performance failures.
- Compliance: Ensure all testing is conducted in strict compliance with the project's Validation Master Plan (VMP) and regulatory standards.
- Stakeholder Management: Liaise with clients, engineering teams, and quality assurance to align on project timelines and deliverable acceptance.
- Reporting: Generate and manage discrepancy reports, change controls, and final summary reports.
Required Qualifications:
- 5 to 10 years of direct experience in Commissioning, Qualification, and Validation within the Pharmaceutical or Biotech industry.
- Proven track record of executing C&Q for clean utilities (Purified Water, WFI, Pure Steam, Compressed Air, HVAC) and/or process equipment (Fermenters, Bioreactors, Filling Lines, Autoclaves).
- Strong knowledge of GAMP 5, ASTM E2500, and 21 CFR Part 11 compliance.
- Proficiency in using standard C&Q documentation software and calibration tools.
- Expertise in CSV (Computerized System Validation) for automation systems, including validation of ERP, MES, SCADA, and laboratory systems (e.g., Empower, LabWare) per GAMP 5 guidelines.
- Experience with DeltaV, Siemens PCS 7, or similar BMS/EMS systems is a plus.
- Six Sigma or Lean methodologies are advantageous.
- Flexibility: Must be comfortable with immediate mobilization and extended stays at client sites.
- Communication: Excellent written and verbal English communication skills for technical writing and client presentations.
- Problem-Solving: Strong analytical mindset to resolve complex technical issues under time constraints.
Working at PQE Group
As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.
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