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Job Details


Senior Environmental Monitoring & Water Specialist

Equipment/Technology Specialist

Equipment and Facilities Specialist

No

Heist op den Berg, Belgium

Job Description

Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.

We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress. At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.   

It's going to be an exciting future – come be a part of it!

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

Senior Environmental Monitoring & Water Specialist

Who will support our Sterile Manufacturing department.

Purpose of the Role

Reporting into the Qualified Person Sterile Quality department you will support the realization of new projects, new equipment, new aseptic processes in the Sterile Manufacturing department. You will control the application of cGMP guidelines by evaluating (updates of) pharmacopoeia, corporate guidelines, EU guidelines etcetera and you will propose documentation to be made to stay in compliance. You will be part of the Quality department and support the Sterile Manufacturing department.

Main Responsibilities

People

  • Responsible for the realization of the project and where appropriate lead the project team;
  • Coordinate with internal and external clients and/ or suppliers of the project;
  • Keep other departments (e.g. Planning, Validation department, …) informed on progress of projects;
  • Have regular meetings with the Environmental Monitoring coach in order to align the planning and stay updated on routine production;
  • Build expertise in the validation of new processes.

Safety

  • Assure a safe working environment and take necessary actions and follow-up;
  • Assure a continuous safety mindset.

Quality

  • Sub-system Owner of Chapter 15 and 35.60 (Environmental Monitoring);
  • Subject Matter Expert of Chapter 19 (Utilities);
  • Assist and prepare for internal and external audits;
  • Build quality into the new systems and projects;
  • Build a compliant, robust and reliable environmental monitoring program based on a quality risk assessment for all processes and routine monitoring and evaluate the program on a periodical base;
  • Build a compliant water sampling program and evaluate the program on a periodical base.

Delivery

  • Where appropriate, set up of the necessary specifications of the project (URS);
  • Support introduction of new sterile processes and equipment;
  • Close follow up of execution, documentation of projects;
  • Follow up on implemented projects.

Costs

  • Where appropriate, monitor the budget projects;
  • Evaluate offers from different suppliers and advice for the ultimate selection;
  • Where appropriate, prepare the necessary documents for the financial department (RFC);
  • Strive for operationally outstanding by:
    • process design;
    • making problems visible and use scientific problem solving tools to continuously improve;
    • share knowledge and successes;
    • coach clients in the new designed processes.

Your Profile

  • Bachelor’s or Master’s degree in Science;
  • At least 3 years of experience in a related sector & similar position;
  • Strong technical writing skills;
  • Team spirit and sense of responsibility;
  • Good planning skills and flexible attitude;
  • Drive for results, learning on the fly and strong problem solving skills;
  • Strong time management, personal learning and priority setting skills;
  • Able to inform stakeholders and organized;
  • Strong oral and written communication skills in English and Dutch.

What do we offer?

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

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.

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.

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID:R510287