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CSV Subject Matter Expert (SME) – Leadership Role in Pharma/Biotech
Are you ready to take ownership of Computer System Validation (CSV) across critical systems in a fast-paced, innovative environment? We’re seeking a CSV SME to lead validation activities for platforms such as eQMS, LIMS, and ERP, ensuring compliance with GAMP 5 and data integrity principles.
What you’ll do:
- Drive CSV strategy and execution across Production, Quality, and IT.
- Develop and review URS, FRS, validation plans, protocols, and reports.
- Oversee IQ/OQ/PQ execution and maintain audit-ready documentation.
- Act as a trusted advisor to Process and System Owners.
- Support audits and inspections, troubleshoot compliance issues, and champion continuous improvement.
What we’re looking for:
- 5–7 years’ experience in CSV within GMP Production/Lab environments.
- Deep knowledge of GAMP 5 and data integrity principles.
- Proven track record as SME during regulatory audits.
- Familiarity with ERP, MES, SCADA, Trackwise, or cloud-based systems.
- Fluent English and German (French is a plus).
- Agile mindset and ability to thrive in cross-functional settings.
Why join us?
- Purpose-driven organization focused on improving patient outcomes.
- Collaborative, growth-oriented culture with minimal bureaucracy.
- Competitive rewards package including pension and annual bonus.
- High-visibility role in a rapidly growing CDMO.
Planet Pharma is an equals opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation, or age.
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