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.