CSV Expert - PCS 7

A leading biopharmaceutical organization is seeking a CSV Expert with strong PCS 7 expertise for a high-impact project involving the extension of a GMP manufacturing building. This freelance role will support equipment qualification, associated recipe validation, and assess CSV impacts across systems and facility infrastructure.

The ideal candidate will be a strong communicator with a collaborative mindset, capable of working across technical teams (automation, mechanical, process, QA) in a fast-paced, regulated environment.

Key Responsibilities:

• Act as CSV Subject Matter Expert (SME) for new equipment and system integration as part of the facility expansion project.
• Define, implement, and execute CSV strategies in line with GAMP 5, Annex 11, and 21 CFR Part 11 for PCS 7-based automation systems.
• Lead validation activities for equipment and associated process control recipes.
• Evaluate CSV-related impacts on the facility infrastructure, including interfaces with utilities, cleanrooms, and building systems.
• Draft and review validation documentation (URS, Risk Assessments, IQ/OQ/PQ protocols, validation plans, and reports).
• Collaborate daily with automaticians, mechanical engineers, IT, QA, and process owners to align validation activities with project timelines and compliance requirements.
• Contribute to the Site Validation Master Plan (SVMP) and support audit readiness and regulatory inspections.

Ideal Profile:

• Master’s degree in science, engineering, or equivalent technical field.
• 5+ years of CSV experience in a GMP manufacturing environment; specific experience with PCS 7 is essential.
• Experience qualifying equipment, control systems, and facility-related systems in a regulated setting.
• Strong interpersonal and communication skills; ability to navigate cross-functional collaboration with technical and non-technical stakeholders.
• Fluent in French and English.
• Self-motivated, organized, and solution-oriented with a proactive approach.

What’s Offered:

• Competitive freelance compensation
• 3-month contract to start, with high likelihood of renewal throughout the 18-month project
• Chance to play a key role in a strategic GMP facility expansion for a major player in the biopharmaceutical sector

Disclaimer:

Amoria Bond is an independent recruitment consultant specializing in sustainable recruitment. None of the terms used in this advert are (in)directly intended to exclude candidates on the basis of age and experience. We hereby confirm that we are accepting applications from suitable candidates regardless of age and experience.