csv sme

vor 1 Tag

Visp Valais, Schweiz Planet Pharma Vollzeit

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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