Work Schedule

Environmental Conditions

Job Description

Introduction:

The Tilburg site develops and manufactures gelatin-based drug delivery dosage forms. It has been a Thermo Fisher Center of Excellence since 1994, with extensive capabilities for various soft gel technologies. The site supplies medicine for important diseases and supports the innovation of new consumer products.

We need an experienced Computerized System Validation Engineer (CSV) to help with our digitalization and automation efforts. The CSV engineer will play a crucial role in the site transition and work closely with our IT organization.

Job description:

The role is within the validation team. The CSV engineer will work closely with manufacturing, IT, supply chain, and quality departments.

The responsibilities include leading GxP CSV projects to ensure compliance with cGMP, 21 CFR Part 11, GAMP5, and Annex 15. The CSV engineer is responsible for validating GxP systems, aligning with requirements, industry practices, and company policies. Projects may involve manufacturing, laboratory, and facility systems in a regulated environment. Familiarity with validation of cGMP automation/computerized systems is required, along with knowledge of industry standards and practices for computer validation. Relevant experience in validating Manufacturing and Laboratory systems in the pharmaceutical industry is essential for this role.

Hands-on experience in drafting documentation specific for computerized system validation, performing validation activities, and reporting the results are the main requirements for this role.

The computerized systems validation engineer should have a background in project management to help automate and digitize our processes and systems. They should be able to manage multiple projects and have strong communication skills.

Given the multitude of projects running within the validation department, sound decision-making in time-sensitive and sophisticated situations with a good assessment of risk are encouraged skills.

Qualifications:

Successful candidates will enjoy a collaborative, technical environment. Experience in pharmaceutical validation (7-10 years) preferred. Bachelor's degree in IT, Science, or related field, or equivalent knowledge/skills required. Must excel in a matrix organization, balancing priorities.

While this position offers the chance to gain experience in various aspects, having a solid foundation in validation, GMP, pharmaceutical manufacturing, or IT would be advantageous.

Personal:

Diversity in our organization is an important element to build an effective and challenging working environment. Integrity, Intensity, Innovation, and Involvement are basic characteristics that we expect of all members of our organization.

A person who enjoys leading change and working within the matrix organization to improve internal processes, with a “can do” mentality, will discover happiness in this role.