Thermo Fisher Scientific zoekt een

Engineer I, Validation

Tilburg, Netherlands

Job Description

Within Patheon Softgels BV, part of Thermo Fisher Scientific in Tilburg, we are accountable for the development and production of Softgel capsules. The validation department plays a key role in this by coordinating, planning, completing and reporting equipment, cleaning and process validation activities. This department works closely with the development, quality and production departments and ensures the validation status of both existing and new processes and equipment being involved in all investment projects.

Within the validation team, the Validation Engineer plans, implement and document validation/qualification activities. In addition, Validation engineer will be appointed to lead project related validation deliverables.

What are you going to do?

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

• Drafts and as well, 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 PPQ, 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 and other audited documents

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

• Validation of SME for internal and external audits

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

Qualification Requirements

Qualifications :

We encourage candidates that enjoy working in a multi-disciplinary, highly technical environment where personal development and team collaboration are keys to success. It is an advantage to have experience (1 - 3 years) working for validation in pharmaceutical industry. A bachelor or university degree in one of the target areas for the position (e.g. technology, science or related field) or confirmed mastering of knowledge and skills required for this position is helpful, combined with desire to learn and will to educate in various aspects of process/system validation is important. The individual should thrive into a matrix organization, handling the complexity of the interface between functional and project organization and balance all priorities.

While there’s room in this position to learn and grow experience in all of the different aspects of role and responsibility, there’s certainly a benefit in already having a solid background on one or more of the involved areas like validation, GMP and pharmaceutical manufacturing.

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