Engineer I, Validation

Job Description

At Thermo Fisher Scientific, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always on top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building an exciting career with us.

Within Patheon Softgels BV, part of Thermo Fisher Scientific, we develop and manufacture Softgel capsules.

Validation department is accountable for qualification and validation status of GMP equipment, systems and processes. Our department works closely with the development, quality and production and supports the new investment projects on site.

What are you going to do?

Responsible for some or more of the activities below.

• Develop protocols, reports, and procedures to ensure that qualifications and validations are consistent with the current regulatory guidelines and requirements, and actual technologies applied in pharmaceutical industry.

• Collaborate with the engineering, manufacturing, and quality teams to align with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) rules and regulations.

• Work within multi-functional teams to ensure validation activities align with production schedules, project timelines and quality expectations.

• Provide technical expertise and guidance on validation-related issues to project teams and collaborators.

• Perform risk and impact assessments related to validation activities and propose appropriate mitigation strategies.

• Draft, review and amend procedures, validation master plan and other audited documents such as standard operating procedures (SOPs) and work instructions (WI) to ensure accuracy and completeness.

• Writes process performance qualification, continued process verification and cleaning validation protocols.

• Perform process validation, continued process verification (CPV) and cleaning validation including work planning, protocols drafting, activities supervision and tests results reporting and documentation.

• Monitor periodic assessment timelines, prepare, and write periodical reviews for critical equipment, utilities, processes including CPV and annual cleaning confirmation.

• Driving improvements in process and cleaning validation methods and strategy and ensuring site wide implementation of the proposed improvements.

• Support internal and external audits and act as SME with validation expertise in communication with inspectors and authorities.

Qualification Requirements

• HBO/University diploma in the field of technology or laboratory and supplemented knowledge with specific training in validation field of expertise and/or 3 - 5 years of confirmed ability in a comparable position within the pharmaceutical industry possessing qualities and affinity with technology.

• Knowledge of validation techniques and ability to generate validation protocols and reports.

• Knowledge of FDA, EU GMP Annex 15, ISPE, ICH 7-10, ISO standards and other pharmaceutical guidelines and quality systems.

• Work accurately, systematically and in detail, both independently and in a team.

• Affinity for project-based work and automated production processes

• Pragmatic and good communication and reports writing skills

• Good speaking and writing skills in the Dutch and English language.