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Cleaning validation engineer

Heist-op-den-Berg
Publiée le 27 septembre
Description de l'offre

Job Description

At our site in Heist-op-den-Berg, we produce and package impactful medicines. With over 1,100 employees, we ship more than 100 different products and approximately 190 million packages each year. Working at Organon means collaborating with dedicated colleagues in an international pharmaceutical company. The site is easily accessible without traffic jams and close to home. You’ll have room to grow, develop yourself, and show who you are. You can count on a competitive salary, 41 vacation days, hospitalization and group insurance, meal vouchers, and—most importantly—a truly pleasant working environment.

This way, you make a difference not only for our customers but also for yourself.

For our Manufacturing Site in Heist-op-den-Berg we are currently looking for a:

Cleaning Validation Engineer

The Position

As a Cleaning Validation Engineer, you play a key role in the development, validation, and continuous improvement of cleaning processes for equipment and tools. You will gain expertise in various cleaning technologies, ranging from manual to fully automated systems, and work closely with a team of fellow Cleaning Validation Engineers. You typically focus on one or two specific areas within the Heist Production Operations, becoming the go-to expert for cleaning-related matters in those units.

Welcome to our team

The team is composed of five experienced Cleaning Validation Specialists, led by a manager. Each specialist is responsible for one or more production units, ensuring thorough support and coverage across the site.

Responsibilities

* Act as the expert and first point of contact for all cleaning-related projects and issues within your designated area.
* Serve as the Subject Matter Expert (SME) for cleaning processes, including both hardware and software aspects.
* Understand the needs and challenges of Production and collaborate closely with cross-functional teams.
* Support cleaning aspects of new product and equipment introductions.
* Lead both proactive and reactive improvements to existing cleaning processes.
* Manage change control activities, including drafting plans, protocols, and reports, and executing studies (e.g., sampling, lab coordination).
* Address deviations and urgent issues in Production to ensure operational continuity.
* Demonstrate flexibility when needed—such as adjusting daily plans, coming to site while working remotely, or working overtime/early/late shifts.
* Participate in periodic cleaning validation activities, including paper-based reviews and sampling programs.
* Over time, be recognized as a site topic lead and contribute to cross-site teams with other cleaning validation experts.

Required Education, Experience, and Skills

* Higher scientific degree in Pharmaceutical Sciences, Bioengineering, or Industrial Engineering.
* Minimum of 3 years of relevant experience in validation within a GMP production environment.
* Hands-on experience in regulated pharmaceutical manufacturing environments.
* Willingness to occasionally work early/late shifts, extra hours, or weekends to support business continuity.
* Analytical and project-oriented.
* Strong problem-solving skills, especially in investigating failed validation data.
* Process- and data-driven approach.
* Excellent communication skills across all levels—from shop floor Operators to Manufacturing Directors.
* Outstanding influencing skills.
* Team player with an on-the-floor approach.
* Customer-focused mindset.
* Fluent in both Dutch and English, verbal and written.

Preferred Experience, and Skills

* Experience in cleaning validation.
* Knowledge about operating principles of cleaning and CIP processes.

What do we offer?

* Interesting work environment with a lot of opportunities for growth.
* Very competitve salary.
* Bonus plan.
* 20 days of annual leave and 21 “ADV” days.
* Meal vouchers.
* Attractive collective health care insurance package.
* Solid Pension Plan.

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.

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

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

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