CQV Engineer

About

We are seeking experienced CQV Engineers to support a major greenfield biopharmaceutical manufacturing project focused on the Bulk Manufacturing (Drug Substance) area. This position will involve ownership of key process and utility systems throughout the full CQV lifecycle, from early design phases through qualification and operational handover.

The successful candidate will play a critical role in ensuring systems are delivered safely, compliantly, and in line with GMP and project expectations within a fast-paced project environment.

Key Responsibilities

• Take ownership of assigned bulk manufacturing process and utility systems
• Support design and technical reviews to ensure alignment with GMP, process requirements, and user specifications
• Develop, review, and execute CQV lifecycle documentation including:
  • URS
  • Risk Assessments
  • Design Qualification (DQ)
  • Traceability Matrices
  • Commissioning and qualification protocols/reports
• Coordinate and support FAT, SAT, commissioning, and qualification activities including IQ/OQ/PQ as applicable
• Work closely with Engineering, Automation, QA, Validation, Construction, and Operations teams to drive system completion
• Track system status, open actions, deviations, and punch list items to support project milestones
• Support risk-based verification strategies aligned with ASTM E2500 methodologies
• Ensure systems are fully prepared for turnover to validation and manufacturing operations

Requirements

• 4–7 years’ experience within CQV, Process Engineering, or Validation in GMP-regulated pharmaceutical or biotech environments
• Strong experience with process equipment and system qualification within bulk manufacturing facilities
• Solid understanding of CQV lifecycle activities and GMP documentation practices
• Previous involvement in large-scale CAPEX, expansion, or greenfield projects
• Familiarity with risk-based qualification approaches and ASTM E2500 principles
• Ability to work effectively within cross-functional project teams and demanding delivery schedules
• Experience using electronic validation systems such as Kneat is advantageous