Commissioning & Qualification (C&Q) Engineer (Dutch Speaker)

Job Description

Commissioning & Qualification (C&Q) Engineer (Dutch Speaker)

Purpose of the role

The Commissioning & Qualification (C&Q) Engineer plays a pivotal role in ensuring that technical projects are executed in full compliance with GMP requirements. The position involves planning, coordinating, and carrying out commissioning and qualification activities for equipment, systems, and utilities—from project execution through to final handover. 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 purpose, properly documented, and ready for operational use. In doing so, the role contributes directly to product quality, regulatory compliance, and safe manufacturing operations.

Welcome to the team

Engineering & Site Strategy is a Center of Excellence within Pharmaceutical Operations. In this role, you report directly to the Engineering & Site Strategy lead and support the Project Managers in delivering investment projects at the Oss manufacturing site. With an annual budget of €30–50 million, the team is responsible for executing production scale-ups and implementing modifications to facilities and/or production equipment.

Main responsibilities

• Support the development of User Requirement Specifications (URS) and perform structured Quality Risk Management (QRM) analyses in line with ISPE guidelines.
• Define, develop, and maintain a comprehensive C&Q strategy and plan, ensuring full alignment with GMP requirements and project objectives.
• Coordinate and oversee all commissioning activities across the project lifecycle, including Design Qualification (DQ), Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT).
• Act as a senior C&Q engineer with a strong coordinating role, providing functional guidance and day-to-day direction to a team of approximately 4–5 engineers, as well as external partners, without formal line management responsibility.
• Ensure alignment and consistent execution across all C&Q activities by establishing clear ways of working, standards, and best practices.
• Review and challenge vendor documentation and test results to ensure compliance with design specifications and regulatory expectations.
• Lead and perform on-site commissioning activities (mechanical, electrical, and functional), ensuring systems are installed and operated as intended.
• Prepare, execute, and approve IQ/OQ protocols (preferably in paperless environments), ensuring systems are delivered fully qualified and backed by complete, audit-ready documentation.
• Own deviation management and change control processes within the C&Q scope, ensuring timely resolution while safeguarding product quality and project timelines.
• Drive effective handover to Technical Operations (for PQ) and to Production, Facility Management, and Maintenance, ensuring clear documentation, asset integration (e.g., Athena), and training of end users.
• Facilitate continuous improvement by capturing lessons learned, driving standardization, and reducing lead times in future projects.
• Act as a key point of contact within the project team, aligning stakeholders, maintaining progress, and ensuring a proactive, solution-oriented approach throughout execution.

Your profile

• Bachelor’s degree in a technical field, or equivalent through experience.
• 5–10 years of relevant experience in the pharmaceutical industry or another highly regulated environment.
• Solid knowledge of EU-GMP (including Annex 1), GEP, QRM, ISPE guidelines, EHS, and Lean principles.
• Proven experience with C&Q activities and developing related protocols within project environments.
• Familiar with project management principles and working in structured project settings.
• Ability to operate as a senior engineer with a coordinating role, providing functional guidance to a team of approximately 4–5 engineers (without formal line management responsibility).
• Strong communication skills, with the ability to engage, align, and motivate stakeholders at different levels.
• “Safety First, Quality Always” mindset.
• Proactive, self-starting, and able to prioritize effectively, with a hands-on “go-see” attitude.
• Service- and customer-oriented.
• Fluent in Dutch and English, both written and spoken.
• Proficient in Microsoft Office.
• Available full-time.

We offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.

• 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.

With Organon, your career is more than just a job — it’s a journey of purpose, impact, and leadership. Together, we are building innovative solutions that improve health and change lives around the globe. If you're ready to grow, lead, and be part of something bigger — we want to hear from you!

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.

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. 

Search Firm Representatives Please Read Carefully 
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

No Travel Required

Flexible Work Arrangements:

Not Specified

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1