Work Schedule

Environmental Conditions

Job Description

Introduction:

Patheon Softgels BV, part of Thermo Fisher Scientific in Tilburg, is responsible for the development and production of Softgel capsules. The validation department is essential in this process as it coordinates, plans, completes, and reports the activities related to equipment, cleaning, and process validation. Working closely with the development, quality, and production departments, this department ensures the validation status of both new and existing processes and equipment, and actively contributes to investment projects.

Within the validation team, the Validation Engineer plans, implements, and documents validation/qualification activities. In addition, the Validation Engineer will be appointed to lead project-related validation deliverables.

Job Description:

• Offers expertise for designing and qualifying new equipment and systems, changing existing processes and systems, expanding production, facility, and implementing new and transferred products.

• Co-drafts User Requirement Specifications (URS) within a multi-functional team and with suppliers.

• Drafts and performs implementation of protocols for C&Q/IQ/OQ/PQ related to equipment, utility, processes, cleaning, and computer validation, including reports and advice regarding periodical review frequencies.

• Writes cleaning validation and Continued Process Verification (CPV) protocols.

• Writes periodic validation reports for critical equipment/utilities/processes, including Continued Process Verification (CPV).

• Provides validation technical support within other departments.

• Drafts, reviews, and amends procedures, Validation Master Plan, and other audited documents.

• Remains abreast of the current developments and regulations for the pharmaceutical industry.

• Validation of SME for internal and external audits.

• Ensures the validated status of all cGMP-critical automated process applications and quality systems.

Qualifications requirements:

• Proven hands on experience in Commissioning and Validation gained preferably within a Pharmaceutical environment or equivalent that is a highly regulated environment

• Ability to review and extract information from systems and put together reports for Periodic Review

• Strong communication skills

Personal:

Diversity in our organization is an important element to crafting 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 working within the matrix organization to improve internal processes, with a “can do” mentality, will discover happiness in this role.