Senior C&Q Consultant

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).

• 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.

• 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, Lab Ware) 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.

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.