C&Q Engineer (12 months)

Overview

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