Job Title: Validation Lead

Experience Level: 8+ Years

Location: Hechingen, Germany

Employment Type: Contract

Industry: Life Sciences Industry

Job Summary:

The Validation Lead is responsible for developing and executing strategic validation initiatives to ensure that systems, processes, and products meet regulatory and business requirements throughout their lifecycle. This role involves oversight of the entire validation process, risk assessments, documentation, stakeholder alignment, and audit readiness. The Validation Lead acts as the key point of contact for cross-functional collaboration and communication with QA, IT, Business, and System Owners to ensure compliance with global regulations and internal quality standards.

Key Responsibilities:

• Lead the development and execution of comprehensive validation strategies for systems, processes, software, and equipment, ensuring alignment with regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, and GAMP5.
• Collaborate with cross-functional teams (e.g., QA, IT, Engineering, Business, Development) to define validation scope, priorities, and resource needs.
• Conduct and oversee risk assessments, impact analyses, and risk mitigation planning in collaboration with System Owners and Business Owners.
• Ensure timely preparation, execution, and approval of validation lifecycle documentation including URS, FRS, Design Qualification (DQ), IQ, OQ, PQ, Validation Plans and Reports, Traceability Matrices, Change Controls, and Periodic Reviews.
• Maintain traceability and audit readiness of all validation deliverables, ensuring proper documentation management and compliance.
• Manage training compliance for validation teams and project stakeholders; ensure that roles are trained appropriately per project and regulatory needs.
• Support internal and external audits and inspections by preparing validation evidence and leading the response to validation-related inquiries.
• Mentor junior validation staff and drive continuous improvement initiatives to enhance validation efficiency and compliance.

Required Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Engineering, Computer Science, or a related field.
• 8+ years of validation experience within regulated industries (pharmaceuticals, biotech, or medical devices).
• In-depth knowledge of regulatory requirements (FDA 21 CFR Part 11, GxP, GAMP5, EU Annex 11) and validation best practices.
• Proven leadership experience in managing validation projects across various platforms including LIMS, MES, ERP, CDS, QMS, and lab instruments.
• Strong documentation, planning, and stakeholder communication skills.
• Demonstrated ability to lead cross-functional teams and manage multiple projects simultaneously.

Preferred Skills:

• Familiarity with validation management tools such as ValGenesis, Kneat, or Veeva Vault.
• Knowledge and application of Computer Software Assurance (CSA) principles.
• Experience managing global or multi-site validation projects.
• Lean Six Sigma or Quality certifications (e.g., ASQ CQA, CQE) are a plus.