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.

Welcome to the team

Engineering & Site Strategy is a Center of Excellence within Pharmaceutical Operations. You will report directly to the Engineering & Site Strategy lead and will support the Project Managers in the team with the implementation activities for Investment Projects at the manufacturing site in Oss. With an annual budget of 30 - 50 M€ the team realizes production scale-ups and modifications on facility and /or production equipment

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

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