Freelance Validation Engineer
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For a pharma customer in Antwerp, we are searching for a freelance Validation Engineer to play a key role in ensuring that equipment, systems, processes and facilities are qualified and validated in accordance with GMP requirements and applicable regulatory standards.
Responsibilities
- Develop, review and execute validation and qualification documentation, including Validation Plans, URS, Risk Assessments, IQ, OQ, PQ protocols and final reports.
- Support the qualification and validation of pharmaceutical manufacturing equipment, utilities, facilities and associated systems.
- Ensure all validation activities comply with current Good Manufacturing Practice (cGMP), EU GMP guidelines and internal quality standards.
- Manage validation deviations, investigations, CAPAs and change controls in collaboration with Quality Assurance.
- Perform risk assessments and identify opportunities to improve validation processes and compliance.
- Support equipment commissioning, qualification and handover to operational teams.
- Maintain accurate, complete and audit-ready validation documentation.
- Collaborate with cross-functional stakeholders to ensure validation activities are delivered within agreed project timelines.
- Participate in internal and external audits and support regulatory inspection readiness.
- Contribute to continuous improvement initiatives within the validation and quality framework.
Profile
- Minimum 3 years of experience in validation or qualification within a GMP-regulated pharmaceutical or biotechnology environment.
- Strong knowledge of EU GMP, Annex 15, qualification and validation lifecycle principles.
- Hands-on experience preparing and executing IQ/OQ/PQ documentation.
- Experience with equipment, process, cleaning or utility validation.
- Good understanding of quality systems, including deviations, CAPAs, change controls and risk management.
- Familiarity with GAMP 5, data integrity principles and computerised system validation would be advantageous.
- Strong documentation skills and a detail-oriented approach.
SENIORITY: Medior/Senior
START DATE: December/January
DURATION: 12 Months
EXTENSION: Yes
CONTRACT: Freelance
ONSITE POLICY: Flexible
HOURS PER WEEK: 40
LANGUAGES: Fluent English and Dutch
INTERVIEW PROCESS: 1 stage
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