Senior Specialist, Engineering

Posted 7 Hours Ago
Be an Early Applicant
Heist-op-den-Berg
3-5 Years Experience
Healthtech • Pharmaceutical
The Role
The Cleaning Validation Engineer will develop, validate, and enhance cleaning processes at the manufacturing site, ensuring compliance with validation requirements. Responsibilities include providing technical expertise, leading cleaning process improvements, managing deviations, and acting as a subject matter expert in cleaning procedures.
Summary Generated by Built In

Job Description

Job Title: Cleaning Validation Engineer
Location: Heist-op-den-Berg, Belgium

About the Role
At our Manufacturing Site in Heist-op-den-Berg, we are looking for a Cleaning Validation Engineer to join our team. In this role, you will be instrumental in developing, validating, and improving cleaning processes for equipment and tools across the site. You will specialize in various cleaning technologies, ranging from manual to automated processes, and collaborate closely with other cleaning validation engineers.
 

Your Key Responsibilities

  • Serve as the subject matter expert for cleaning processes in one or two specific areas of the Heist Production Operations, becoming the first point of contact for all cleaning-related projects and challenges in that part of the site.
  • Provide in-depth technical expertise on cleaning processes, including hardware and software aspects, and align with Production to address needs and resolve issues.
  • Lead both proactive and reactive cleaning process improvements for new product and equipment introductions, utilizing change control systems, drafting plans, protocols, and reports, and coordinating sampling and laboratory analysis.
  • Manage deviations and support urgent cleaning-related needs in Production to ensure operational continuity. This may occasionally require flexibility, such as changes in daily planning, working outside of standard hours, or being on-site when working from home.
  • Ensure compliance with cleaning validation requirements, including regular periodic reviews and sampling programs.
  • Over time, develop into a recognized cleaning validation expert and act as the site lead for cleaning validation topics, representing the site in cross-functional teams with other cleaning experts globally.

Your Profile

  • You hold a higher scientific degree (e.g., Pharmaceutical Sciences, Bioengineering, Industrial Engineering, etc.).
  • You have at least 3 years of experience in validation and/or project management within a regulated pharmaceutical manufacturing or laboratory environment.
  • You possess hands-on experience with cleaning processes, including CIP (Clean-in-Place) systems, and have a strong understanding of their operating principles.
  • You have an analytical mindset, are project-oriented, and are comfortable working both independently and as part of a team.
  • You are a true team player with strong customer focus and outstanding influencing skills.
  • You are process- and data-driven with a hands-on approach to problem-solving.
  • You are fluent in both Dutch and English, both verbally and in writing.


What We Offer
We offer a competitive compensation package along with opportunities for professional growth in an innovative and dynamic environment. At Organon, we are committed to fostering a culture of inclusivity, teamwork, and continuous development.


If you’re ready to make a difference in a global company focused on women's health, apply today!

  • An exciting work environment with plenty of growth opportunities;
  • Competitive salary;
  • Incentive plan;
  • 20 vacation days and 21 additional leave (ADV) days;
  • Meal vouchers;
  • Hospitalization insurance and group insurance.

How to Apply
Click on the 'Apply' button to submit your application. We look forward to reviewing your candidacy!

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

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

The Company
HQ: Jersey City, NJ
6,952 Employees
On-site Workplace

What We Do

Organon is a global healthcare company with a portfolio of therapies and products in women’s health, biosimilars, and established medicines across a wide array of conditions and diseases. Our mission is to deliver impactful medicines and solutions for a healthier every day.

This site is intended for residents of the United States and its territories.

You are reminded to protect yourself against recruiting fraud from individuals, organizations or other entities claiming to represent Organon. All official Organon recruitment emails will come from accounts formatted as [email protected] or [email protected], and Organon will never conduct interviews by chat or email, or make job offers through social media or online forums. All candidates for roles at Organon will first meet with a recruiter and interview team, via Teams or in person. Organon will never ask you to make financial transactions on its behalf or ask you to receive or ship packages or goods.

For more information on adverse event reporting, visit http://bit.ly/AEReporting.

To read our community guidelines, visit http://bit.ly/OrganonCommunityGuidelines.

Follow us on Twitter at Organon (@OrganonLLC).
Follow us on Instagram at Organon (@OrganonLLC).

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