Validation Lead

vor 2 Wochen

Hechingen, Baden-Württemberg, Deutschland Grove Technical Resources, INC Vollzeit 90.000 € - 120.000 € pro Jahr

Job Title: Validation Lead (Life Sciences)

Location: Hechingen, Germany (Fully Onsite) | Type: Contract | Experience: 8+ Years

We're seeking an experienced Validation Lead to drive strategic validation activities across systems, processes, and equipment in compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP5, and global quality standards.

Key Responsibilities:


• Lead end-to-end validation for software, systems, and equipment (LIMS, MES, ERP, QMS, CDS, etc.).


• Conduct risk assessments, impact analysis, and ensure full audit readiness.


• Prepare and review validation documentation (URS, FRS, DQ, IQ, OQ, PQ, Reports).


• Collaborate with cross-functional teams (QA, IT, Engineering, Business) to ensure compliance.


• Support audits and inspections, mentor team members, and drive continuous improvement.

Requirements:


• Bachelor's/Master's in Life Sciences, Engineering, or Computer Science.


• 8+ years' experience in validation within pharma/biotech/medical devices.


• Expertise in GxP, GAMP5, CSA, and computer system validation.


• Strong leadership, documentation, and communication skills.

Preferred:


• Experience with ValGenesis, Kneat, or Veeva Vault.


• Exposure to global validation projects and Computer Software Assurance (CSA).

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