Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
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 the organization through coordinating, planning, completion and reporting of equipment, systems, and processes validation activities. This department works closely with the development, quality, engineering and production departments, being responsible for maintaining the qualified validation status of existing process and for validation of the new processes or equipment being involved in all investment projects.
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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 validation engineer responsibilities?
• 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 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 SME for internal and external audits
• Ensures the validated status of all cGMP-critical automated process applications and quality systems.
Qualifications requirements:
We encourage candidates that enjoy working in a multi-disciplinary, highly technical environment where personal development and teamwork 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, will for development and education 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 the different aspects of role and responsibility, there's certainly a benefit in already having a proven background on one or more of the involved areas like validation, GMP and pharmaceutical manufacturing.