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Within Patheon Softgels BV, part of Thermo Fisher Scientific in Tilburg, we are responsible for the development and production of Softgel capsules. The validation department plays a crucial role in this by coordinating, planning, executing, reporting and archiving equipment, cleaning and process validation. This department works closely with the development, quality and production departments. The department is responsible for the validation status of both existing and new processes and equipment and is practically involved in all investment projects.
Within the validation team, the Senior Validation Engineer is responsible for the planning, execution and documentation of validation/qualification activities, if relevant within the project team. In addition, the Sr. Validation engineer will be appointed as leader of specific projects related to validation activities. The Senior Validation Engineer the policy regarding validation/qualification.
What are you going to do?
Responsible for some or more of the activities below depending on the candidate's experience and specific knowledge area
• Provides specific input from validation expertise for the design and implementation of new equipment and systems, change of existing equipment and systems, expansion of production, facility, implementation of new and transferred products
• Co-drafting and assessing User Requirement Specifications (URS) within a multidisciplinary working group and with the suppliers involved
• Drafting and as well responsible for the implementation of protocols for C&Q/IQ/OQ/PQ related to equipment, utility, process, cleaning and computer validation including reports and advice regarding validation frequencies
• Writes and continues process and cleaning validation protocols
• Writes periodic validation reports for critical equipment/utilities/processes including Continued Process Verification (CPV)
• Provides technical support to validation activities within other departments
• Drafting, reviewing and amending procedures, the validation master plan and other audited documents
• Remains abreast of the current state of industry and regulations
• Validation of SME in internal and external audits
• Ensuring the validated status of all cGMP-critical automated process applications and quality systems.
• HBO/University diploma in the field of technology or laboratory and you have supplemented your knowledge with specific training (e.g. statistics) and/or 7 - 10 years of experience in a comparable position within the pharmaceutical industry with demonstrable qualities and affinity with technology
• Knowledge of validation techniques and methods and the preparation of validation protocols and reports
• Knowledge of FDA, EU GMP Annex 15, ISPE, ICH 7-10, ISO standards, GAMP5, FDA 21CFR11 and other guidelines and quality systems
• You work accurately, systematically and in detail, both independently and in a team.
• You have an affinity with project-based work and automated production processes
• You are pragmatic and have good communication skills at production and management level
• Good speaking and writing skills in English language, Dutch would be great
We welcome candidates that enjoy working in a diverse, multi-disciplinary, groundbreaking technology environment where personal development and team cooperation are key to success, to make the impossible -> possible for our customers.
Diversity in our teams is an important element to build an effective and challenging working environment. Integrity, Intensity, Innovation and Involvement are key values that we expect of all that are part of our community.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
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