Commissioning & Qualification; C&Q Engineer

Position: Commissioning & Qualification (C&Q) Engineer
Job Description

Commissioning & Qualification (C&Q) Engineer
Purpose of the role

The Commissioning & Qualification (C&Q) Engineer plays a key role in ensuring that technical projects at the Organon manufacturing site in Oss are delivered in full compliance with GMP requirements. The role involves planning, coordinating, and executing commissioning and qualification activities for equipment, systems, and utilities, from project execution through final handover to the business. By working closely with multidisciplinary internal teams—such as Production, Quality, SHE, Automation, and Maintenance—as well as external partners including engineering firms, suppliers, and contractors, the C&Q Engineer ensures that installations are fit for intended use, properly documented, and ready for operational use.

The role contributes directly to product quality, regulatory compliance, and safe manufacturing operations.

Main Responsibilities

Provide support for User Requirement Specifications (URS) and develop risk analyses (Quality Risk Management in line with ISPE Baseline® Guide Vol.
5).

Develop a complete, approved C&Q plan addressing all critical GMP requirements.

Coordinate commissioning activities, including preparation and execution of protocols for Design Qualification (DQ), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT).

Review and confirm manufacturer testing to ensure compliance with the approved design.

Perform on-site commissioning activities (mechanical, electrical, and functional).

Verify that installations provide documented evidence of compliance with IQ/OQ requirements, with no open issues.

Prepare and execute Installation Qualification (IQ) and Operational Qualification (OQ), preferably using paperless systems.

Deliver fully qualified systems supported by a complete, audit-ready documentation package.

Manage deviations and change control processes throughout the project lifecycle.

Ensure timely closure of deviations, minimizing impact on product quality and project timelines.

Lead handover to Technical Operations for Performance Qualification (PQ) and/or to Production, Facility Management, and Maintenance departments.

Ensure clear and complete handover documentation; train operators and technicians; integrate assets into the Athena maintenance system.

Facilitate continuous improvement initiatives and lessons-learned sessions.

Drive improved standards and reduced lead times for future projects.

Ensure consistent execution of C&Q activities by internal engineers and external C&Q partners.

Maintain uniform working methods across all C&Q engineers (currently three), ensuring alignment and best practice adoption.

Your profile

Bachelor’s degree (polytechnic or academic) in a technical field or similar through experience.

Extensive work experience (5 to 10 years) in the pharmaceutical industry, or similar, highly regulated environment.

Familiar with EU-GMP, Annex 1, GEP, QRM requirements, ISPE guidelines, EHS guidelines and Lean principles.

Communication skills, able to inspire and energize your project team (higher management and craftsmen).

Experience in drawing up protocols and carrying out C&Q activities as part of projects in the pharmaceutical industry.

Safety First and Quality Always mindset.

‘Self-starter’, independent, ability to prioritize.

Proactive and “Go-see” attitude.

Service and customer oriented.

Communicate in Dutch and English (both verbal and in writing).

Able to work with Microsoft Office.

Experience with and knowledge of project management.

Available full-time.

We offer

Competitive salary and a 3% year-end bonus.

35.5 days of leave.

Attractive collective health care insurance package with considerable reduction rates.

Solid Pension Plan.

Incentive Plan (bonus).

Commuting allowance.

Numerous training, coaching and e-learning modules for long term job opportunities and development.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

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