QA CSV Engineer

We are seeking a QA CSV Specialist for a high-profile sterile drug product project. You will support the design and qualification of a new aseptic manufacturing suite, acting as a key QA liaison to ensure compliance across CSV, CQV, and automation streams from initial design through to Equipment PQ.

This is a 12-month hourly rate contract position.

Responsibilities:

• Provide QA support and approval for CSV/CQV activities, including validation plans, protocols, and reports.
• Review and approve GMP documentation, including SOPs, Deviations, CAPAs, Change Controls, and Risk Assessments.
• Work closely with cross-functional teams to ensure robust contamination control strategies and successful knowledge transfer.
• Support the transition from project phase to GMP operations, ensuring all systems meet regulatory standards.
• Drive safe working practices and support Operational Excellence initiatives (e.g., Kaizen, Standard Work, Lean methodologies).

Requirements:

• Bachelor's or Master's degree in Engineering, Science, or a related technical discipline.
• Deep understanding of EU GMP Annex 1 principles and their application in sterile manufacturing environments.
• Proven track record in Computer Systems Validation within a regulated life sciences environment.
• Ability to work independently in a fast-paced, matrix environment. Excellent communication, time management, and organizational skills are essential.