CQV Engineer - GMP Validation & Quality Assurance

EPM Scientific; Antwerpen; Sur place; EUR 70 000 - 110 000; Plein temps

Description du poste

Overview

We are seeking an experienced QA Qualification / Validation Engineer to join a highly regulated pharmaceutical manufacturing environment. This role provides Quality Assurance oversight for qualification, validation, commissioning, and lifecycle management activities related to manufacturing systems, process equipment, laboratory equipment, facilities, and utilities. The successful candidate will work closely with Engineering, Manufacturing, Maintenance, Validation, and Quality teams to ensure that critical systems remain qualified, compliant, and inspection-ready throughout their lifecycle. This position requires a strong quality mindset, excellent stakeholder management skills, and the ability to apply risk-based decision making within a GMP-regulated environment.

Key Responsibilities

• Provide Quality Assurance support and oversight for qualification, validation, commissioning, and lifecycle management activities.
• Review and approve qualification and validation documentation, including:
  • User Requirements Specifications (URS)
  • Risk Assessments
  • Impact Assessments
  • DQ / IQ / OQ / PQ protocols
  • Test scripts
  • Qualification and validation reports
  • SOPs and related quality documents
• Ensure qualification and validation activities are executed in accordance with GMP regulations, industry standards, and internal quality procedures.
• Support qualification and requalification activities for process equipment, laboratory equipment, manufacturing systems, facilities, and utilities.
• Participate in change control activities and assess quality, compliance, and validation impacts.
• Review and approve deviations, investigations, non-conformances, and CAPAs related to qualified systems and equipment.
• Ensure that risk-based methodologies are appropriately applied throughout the qualification and validation lifecycle.
• Support the qualification status and compliance of critical production assets through effective lifecycle management.
• Review procedures related to qualification, calibration, maintenance, asset management, and system lifecycle activities.
• Collaborate with cross-functional stakeholders to ensure project objectives, timelines, and compliance requirements are achieved.
• Participate in remediation, optimisation, and continuous improvement initiatives to strengthen quality and compliance standards.
• Support regulatory inspections, customer audits, and internal assessments while acting as a subject matter expert in qualification-related topics.
• Maintain current knowledge of international regulations, GMP requirements, industry guidance, and qualification best practices.

Required Experience

• Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, or a related discipline.
• Minimum 5 years of experience within a GMP-regulated pharmaceutical, biotechnology, biologics, or life sciences environment.
• Experience supporting Quality Assurance, Qualification, Validation, C&Q, or CQV activities.
• Strong understanding of GMP requirements and quality systems.
• Proven experience reviewing and approving qualification and validation documentation.
• Experience managing or supporting:
  • Change Controls
  • Deviations
  • Investigations
  • CAPAs
  • Risk Assessments
• Knowledge of qualification lifecycle management principles.
• Strong communication and stakeholder management skills.
• Ability to challenge constructively while maintaining positive working relationships.
• Fluent English.
• Dutch language skills preferred or required depending on site requirements.

Preferred Experience

• Process equipment qualification.
• Laboratory equipment qualification.
• Qualification activities within commercial or clinical pharmaceutical manufacturing.
• Sterile manufacturing environments.
• Filter integrity testing and qualification activities.
• Change controls, non-conformance management, and investigation ownership.
• Remediation and requalification of legacy systems.
• Pharmaceutical Quality Assurance supporting manufacturing operations.

• CAR-T, Cell Therapy, ATMP, Gene Therapy, or Biologics manufacturing.
• Facilities & Utilities (F&U) qualification.
• Commissioning, Qualification & Validation (CQV) programmes.
• Critical production asset management.
• Calibration strategy, calibration rationales, and maintenance programmes.
• Data integrity reviews including audit trail reviews and user access reviews.
• Computerised systems and manufacturing systems compliance.
• Supporting FDA, EMA, and health authority inspections within advanced therapy environments.

Ideal Candidate Profile

You are a quality-focused professional with strong experience in qualification, validation, and compliance activities within a regulated pharmaceutical or biotechnology environment. You combine technical knowledge with a practical, risk-based approach and are comfortable working with engineering, manufacturing, and quality teams to ensure systems remain compliant throughout their lifecycle. You communicate effectively, challenge constructively, and thrive in environments where quality and patient safety are critical.