CQV Engineer

Responsibilities

• Act as System Owner for assigned equipment within Bulk or Fill Finish areas
• Participate in design reviews and ensure alignment with URS and GMP requirements
• Lead and/or support development of GxP documentation (URS, SRA, DQ, RTM, protocols)
• Support commissioning and qualification activities (FAT, SAT, IQ/OQ/PQ where applicable)
• Manage and track system deliverables in line with project schedule
• Cookordination with CQV, Engineering, Automation, QA, and Construction teams
• Identify and manage risks, issues, and dependencies related to assigned systems
• Support verification planning aligned to ASTM E2500 methodology
• Ensure systems are ready for handover to validation/operations

Requirements

• 47 years' experience within CQV / Process Engineering in GMP environments
• Hands-on experience with system ownership and equipment qualification
• Strong understanding of CQV lifecycle and GxP documentation
• Experience working on large CAPEX or GMP manufacturing projects
• Familiarity with ASTM E2500 / risk-based qualification approaches (preferred)
• Ability to work in a cross-functional, fast-paced project environment
• Familiarity with KneTelecommunicationrade; (electronic CQV documentation platform) is a nice to have