Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Please Note:

At this time, we are not actively recruiting for this position. We are collecting interest for potential future opportunities. If you express interest, we will keep your information on file and the Talent Acquisition team may contact you when the role becomes available.

Netherlands' sites: Tilburg, Groningen, Naarden, Leiden, Lelystad

Job Description

When you’re part of Thermo Fisher Scientific, you’ll do meaningful work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

Location/Division Specific Information

Our Tillburg, NL facility offers commercial manufacturing and development of gelatin based drug delivery dosage forms (softgels). Tilburg has been a Thermo Fisher Center of Excellence since 1994, offering extensive capabilities for a variety of softgel technologies.

Specialized CapabilitiesProduct development expertise from pre-formulation into commercial product for Prescription(Rx), Over-The-Counter (OTC) and Nutraceutical dosage formsManufacturing of clinical suppliesManufacturing with use of specific proprietary softgel technologies (e.g. Chewels, Liquisoft and Entericare)Manufacturing with use of gelatin from different origin: bovine bone, porcine, fishColor matching and development for various dosage formsTaste masking development for chewable dosage formsFormulation & analytical development for low solubility compounds; Solubility screeningDevelopment and small-scale manufacturing of High Potent (Up to class 3b) compounds

Our Tillburg facility also has a track record of strong regulatory compliance from various international regulatory inspection agencies.

How you will make an impact:

We are seeking a highly skilled and motivated Validation Engineer to join our dynamic team. The Validation Engineer will be responsible for ensuring that our systems, processes, and products meet all vital regulatory standards and specifications. This role involves extensive testing, documentation, and analysis to validate the performance and compliance of our solutions.

What will you do:

Develop and implement validation protocols and test plans for systems, processes, and products.Perform risk assessments and identify critical control points within systems and processes.Prepare and maintain detailed validation documentation, including validation plans, reports, and traceability matrices.Collaborate with multi-functional teams such as Quality Assurance, Regulatory Affairs, and Engineering to ensure compliance with industry standards and regulations.Analyze test data and results to identify trends, deviations, and areas for improvement.Ensure that all validation activities are completed on time and within budget.Offer training and support to team members regarding validation procedures and standard methodologies.Stay updated with the latest industry standards, guidelines, and regulatory requirements related to validation.

How will you get here:

Bachelor’s degree in Engineering, Science, or related field.Minimum 5 years experience in validation engineering or a related role.Work experiences with computer system validation (CSV).Strong understanding of validation principles, practices, and methodologies.Knowledge of regulatory requirements such as FDA, EMA, and ISO standards.Excellent analytical, problem-solving, and organizational skills.Proficient in technical writing and documentation.Ability to work independently and as part of a team.Strong communication skills and attention to detail.

Preferred Qualifications:

Experience in the pharmaceutical, biotechnology, or medical device industry.Certification in validation or related field.Familiarity with computer system validation (CSV).

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com