Delpharm Development Leiden is looking for a Validation Engineer | Fulltime
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We are looking for a Validation Engineer to join our team!
The Validation Engineer plays a key role in the Facilities team, responsible for developing, executing, and maintaining validated equipment for sterile injectable pharmaceutical manufacturing in compliance with GMP. The role reports directly to the Head of Facilities and interacts with regulatory, Quality Assurance, formulation and engineering team

• Plan, write, execute and review User Requirement Specifications (URS)
• Develop, review and execute validation protocols (IQ/OQ/PQ) for new and existing production equipment, facility systems and utilities within a sterile environment.
• Ensure all validation activities are conducted according to GMP, company policies and regulatory requirements, such as EU GMP Annex 1 principles.
• Act as a key liaison between the site, external vendors and internal teams to guarantee the implementation and standardization of validation approaches.
• Create, review and maintain validation documentation, including validation master plans, qualification protocols and summary reports, traceability matrices and risk assessments.
• Lead periodic validation reviews to ensure compliance and execute revalidation activities as required.
• Collaborate with Quality Assurance, Engineering, and Production (and formulation) to troubleshoot deviations, perform root cause analysis and ensure corrective and preventive actions are implemented effectively.
• Engage proactively with cross-functional stakeholders to facilitate timely project completion, offer expert guidance on review and risk assessments and communicate upcoming validation requirements.
• Support regulatory audits by preparing and presenting validation documentation and participating in audit responses.
• Uphold process robustness and product quality by strict alignment to the Quality Management System (QMS), GMP and official industry guidelines, ensuring all validation activities directly support compliance and continuous improvement.
• Manage projects for the commissioning and qualification of new facilities, utilities, and equipment, including participation in FAT/SAT, cleanroom qualification, and automation system validation.
• Maintain and update equipment and validation status databases in collaboration with maintenance and production staff
• Plays a role in annual shutdown program

We are looking for a Validation Engineer with the following profile

• Technical degree in Engineering or related field
• 3+ years of experience in pharmaceutical industry
• Experience in GMP, manufacturing and validation (preferable in sterile environments)
• The ability to work independently and collaboratively with cross functional teams, including Production, QA and formulation