Freelance Validation Engineer - GMP

Vivid Resourcing; Antwerpen; On-site; EUR 111,000 - 166,000; Full time

Job summary

Vivid Resourcing in Antwerp is seeking a freelance Validation Engineer for a pharma project to ensure equipment, systems, processes and facilities are qualified and validated per GMP and regulatory standards. Responsibilities include developing IQ/OQ/PQ docs, risk assessments, deviations, CAPAs, and change controls, with hands-on validation of equipment, utilities and facilities.

The role is 40 hours/week on-site, starting December/January for 12 months, with extension possible and flexible

Qualifications

• Minimum 3 years of validation or qualification experience in GMP pharma/biotech.
• Strong knowledge of EU GMP, Annex 15 and validation lifecycle.
• Hands-on experience preparing 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 and data integrity would be beneficial.

Responsibilities

• Develop, review and execute validation/qualification documentation (IQ/OQ/PQ, validation plans, URS, risk assessments, final reports).
• Support qualification/validation of pharma manufacturing equipment, utilities, facilities and systems.
• Ensure activities comply with cGMP and EU GMP guidelines and internal standards.
• Manage deviations, investigations, CAPAs and change controls with QA.
• Perform risk assessments and identify improvements for validation processes.
• Support equipment commissioning, qualification and handover to operations.
• Maintain audit-ready validation documentation.
• Collaborate with stakeholders to meet timelines.
• Participate in audits and regulatory inspections; support readiness.
• Contribute to continuous improvement within validation framework.

Skills

Validation experience

GMP knowledge

Documentation skills

Risk management

Quality systems

Job description

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