Validation - Engineer (m/f/d) (Remote)
Remote
Job Summary
Lead the planning, execution, and documentation of validation activities for computerized systems, equipment, and processes in compliance with GAMP5, CSV/CSA, and regulatory standards. Generate and review deliverables including validation plans, user requirements, specifications, risk assessments, and test protocols (IQ/OQ/PQ). Implement paperless validation solutions using platforms such as Kneat, Valgenesis, Polarion, DevOps, and Jira while advising on strategic QA initiatives like QMS modernization and Pharma 4.0 methodologies. Collaborate with cross-functional teams including MES/LIMS/SAP specialists to ensure seamless system integration and support audits and inspections with expert guidance on documentation and compliance strategies. Mentor team members and clients on validation best practices and regulatory requirements.
Required Qualifications
- Bachelor's or Master's degree in Engineering, Life Sciences, Computer Science, or a related field
- 3+ years of experience in validation engineering within the pharmaceutical, biotech, or regulated life sciences industries
- Deep knowledge of GMP, GLP, GxP, GCP, and GAMP5 standards
- Proven track record in computer system validation (CSV/CSA)
- Hands-on experience with paperless validation platforms (Kneat, Valgenesis, Polarion, DevOps, Jira, Kneat GxP, Automated Testing tools)
- Strong technical writing skills
- Demonstrated ability to lead validation projects, modernize QMS, and implement new validation methodologies
- Solid understanding of pharmaceutical manufacturing processes, quality control, and regulatory requirements
Desired Qualifications
- Familiarity with MES, LIMS, and SAP systems as secondary skills
- Excellent communication skills, with the ability to work effectively in both consulting and in-house environments
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