Validation Engineer

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

Our organization

Delpharm Leiden is a dedicated development center within the Delpharm network, focusing on injectable dosage forms. Connecting our team of experts with advanced equipment, like our recently acquired HRMS, we position ourselves as specialists in our field. Providing a comprehensive range of services from research & development to clinical phase. Our team, capable of handing potent compounds, sets high standards when it comes to safety, quality and employee well-being. Driven by the aspiration to continuously enhance our services, we apply methodologies such as Quality by Design (QbD), data science and lean principles. These practices not only contribute to the refinement of our internal processes but also enable us to meet the evolving needs of our customers with the end goal in mind: impacting the patients life.

Furthermore, joining Delpharm Leiden means becoming a member of an international and diverse organization. We have a close team fostering lasting connections, where many individuals have dedicated 10 years or more to our collective success. Together with our active Staff Association we arrange several social activities a year and share work, hobbies and personal experiences in our frequent get togethers and our staff magazine. These and many other initiatives allow us to create a rich and supportive community within our workplace

Your responsibilities will include:

• 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

We offer you

• A great place to work within a team of motivated specialist
• Learning and development opportunities
• Market conform salary based on experience (salary range between €4.500 - €5.750)
• Variable pay bonus
• 25 holidays + 6 Delpharm designated days
• Pension scheme including personal options such as partner pension, ANW shortfall and extra savings
• NS business card or Travel allowance
• Laptop