Senior Validation Engineer - Heist-op-den-Berg, België - Organon

Beschrijving

Job Description

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

Senior Validation Engineer

Join our dynamic Pharmaceutical Technical Operations (PTO) team of 15 experienced scientists who are passionate about developing and optimizing pharmaceutical processes and products. We work collaboratively with production and laboratory Integrated Process Teams and various departments at our Organon Heist site and internationally. This PTO team manages cleaning, sterilization, formulation, and filling processes for both non-sterile and sterile products.

The position

The Senior Validation Engineer is key in the development, validation and implementation of the pharmaceutical formulation and filling processes of the products at Organon's Sterile department. The Senior Validation Engineer specializes in different topics, such as process/product validation, process improvement, technology transfer, Container Closure Integrity, Single Use Systems, Primary Packaging Components, Product Contact Materials.

In this role you will report into the PTO lead.

Responsibilities

• Act as a project leader for the realization of larger and more complex technical projects within Sterile department;
• Responsible for the introduction of new processes and sources of APIs, excipients, primary packaging, and product contact materials including Change Control and Risk Management;
• Implementation of process optimization and related projects;
• Become an expert on a certain topic within the validation group;
• Assist the Quality and Production Department in handling deviations and out of specification investigations (or lead said investigations).

Required Education, Experience, and Skills

• Higher scientific degree (Pharmaceutical Sciences, Engineer Bioscience/Chemical/Industrial, ...);
• At least 5 years of relevant experience in pharmaceutical manufacturing environment, validation and/or project management;
• Comprehensive scientific and technological knowledge in sterile manufacturing (preferred);
• Hands-on experience in a regulated pharmaceutical manufacturing and/or laboratory environment;
• Analytical mindset and problem-solving skills;
• Project-minded;
• On-the-floor approach;
• Customer focused;
• Process and data driven;
• Fluency in both Dutch and English (verbal and written).

What we offer:

• An appealing work environment with numerous growth opportunities.
• Competitive salary.
• Incentive Plan.
• 20 holidays and 21 ADV days.
• Luncheon vouchers.
• Hospitalisation and group insurance.

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:

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: