CQV Engineer

The CQV Engineer is responsible for the preparation, review and approval of commissioning, qualification and cGMP documentation across equipment, facilities, utilities, computerized systems and manufacturing/packaging processes within a regulated pharmaceutical manufacturing environment.

The role supports capital and improvement projects from design through commissioning, qualification and handover, working closely with engineering, quality, manufacturing and external service providers to ensure regulatory compliance and inspection readiness.

Key Responsibilities

• Prepare, review and approve CQV and cGMP documentation.
• Provide CQV input across project phases, including design, commissioning and qualification.
• Manage commissioning punch lists, validation deviations and change controls.
• Ensure compliance with current regulatory expectations and data integrity requirements.
• Qualify and manage vendors during commissioning and qualification activities.
• Maintain site-wide cGMP compliance and promote a strong quality culture.
• Manage CQV schedules and timelines in alignment with project plans.
• Collaborate cross-functionally to support project delivery and regulatory readiness.

Qualifications & Experience

• Proven experience acrossCQV disciplines including:
  • Process and packaging equipment
  • Facilities and utilities
  • Computerized systems and automation
  • Cleaning validation
• Strong technical writing skills for GMP documentation (e.g. VMPs, URSs, DQs, FATs, IOQs/OQs, risk assessments, change controls).
• Experience supporting new product introductions and equipment upgrades in processing and packaging environments.
• High attention to detail with strong organisational and stakeholder management skills.
• Project planning experience is an advantage.