Computerized System Validation Engineer II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Tilburg site develops gelatin-based drug delivery dosage forms (soft gels). It's a Thermo Fisher Center of Excellence since 1994, with advanced capabilities for various soft gel technologies.

Seeking an experienced Computerized System Validation Engineer (CSV) Engineer to support digitalization and automation in our production processes.

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. Proven experience in validating Manufacturing and Laboratory systems in the pharmaceutical industry is crucial 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 numerous projects and have strong interpersonal 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:

We seek candidates for a tech-focused, collaborative setting. Prefer 7-10 yrs pharma validation experience.

This position allows learning and gaining experience in various aspects. Having a strong background in areas like validation, GMP, pharmaceutical manufacturing, and IT is helpful.

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 the organization.

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