Remote Engineer:in (m/w/d)

Commissioning & Qualification (C&Q) Engineer

Key Responsibilities

• Support commissioning and qualification activities across the full C&Q lifecycle (DQ, IV, OV, PQ).

• Generate, review, and execute qualification protocols and reports in compliance with GMP and ALCOA+ principles.

• Support FAT and SAT planning, documentation review, execution, and witnessing activities.

• Review supplier documentation, RTMs, and turnover packages to ensure readiness for qualification.

• Conduct installation inspections and support commissioning activities, identifying and managing punch-list items through to closure.

• Perform risk assessments and develop task-specific method statements to support safe execution of activities.

• Provide technical troubleshooting and problem-solving support during testing and qualification phases.

• Monitor progress against project schedules and escalate risks or delays where required.

• Collaborate with engineering, quality, construction, and vendor teams to ensure compliant system delivery.

Requirements

• Experience within pharmaceutical or biotechnology commissioning and qualification environments.

• Strong understanding of the C&Q lifecycle, including URS, DQ, IV, OV, and PQ.

• Familiarity with GMP requirements, ALCOA+ principles, and controlled documentation systems.

• Experience supporting FAT, SAT, commissioning, and qualification activities.

• Strong technical writing, reporting, and communication skills.

• Ability to work independently while managing multiple priorities in a site-based environment.