C&Q Engineer

Ghent

Contract

Negotiable

Quality

CR/609459_1789049439

Location: Ghent, Belgium (On-site)
Contract Type: Consultant / Freelance
Duration: 6 Months
Department: Quality Assurance
Industry: Pharmaceutical Manufacturing
Languages Required: Fluent Dutch and English

Overview

Our client, a leading pharmaceutical manufacturer based in Ghent, Belgium, is seeking an experienced QA C&Q Engineer to support the ongoing compliance and qualified state of manufacturing facilities, utilities, and process equipment.

Working within the Quality function, you will provide quality oversight across commissioning, qualification, validation, and lifecycle management activities, ensuring critical manufacturing assets remain compliant with GMP requirements and regulatory expectations.

This is an excellent opportunity for a quality-focused CQV, Qualification, or Validation professional to contribute to a highly regulated pharmaceutical manufacturing environment on an initial 6-month contract.

Responsibilities

Review and approve qualification and requalification activities for facilities, utilities, and process equipment.
Ensure manufacturing assets remain in a compliant and qualified state throughout their lifecycle.
Review and approve qualification documentation, including protocols, reports, SOPs, change controls, URS, impact assessments, and risk assessments.
Support investigations, deviations, CAPAs, and non-conformances related to qualification activities and manufacturing assets.
Partner with Engineering, Maintenance, Manufacturing, and Quality teams to assess quality and compliance impacts associated with site changes.
Review maintenance programmes, calibration strategies, calibration records, and asset management documentation.
Support data integrity activities, including audit trail reviews and user access reviews for critical systems.
Participate in site compliance initiatives and continuous improvement projects.
Act as the QA representative during audits, inspections, and qualification-related reviews.
Provide quality oversight for commissioning, qualification, and validation activities across the site.

Requirements

Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Chemistry, or a related scientific discipline.
Minimum 4 years of experience within a GMP-regulated pharmaceutical or biotechnology environment.
Strong experience within QA, CQV, Qualification, Validation, Engineering Quality, or Facilities & Utilities Quality.
Good understanding of GMP regulations and EU/FDA requirements.
Experience reviewing qualification lifecycle documentation and associated quality records.
Familiarity with deviation management, CAPA processes, change controls, and quality risk management.
Experience supporting facilities, utilities, manufacturing equipment, or process systems.
Exposure to data integrity programmes, computerised systems, or asset management systems would be advantageous.
Strong stakeholder engagement and cross-functional communication skills.
Fluent Dutch and English, with the ability to work effectively across multidisciplinary teams.

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