Engineer II, Validation - Computerized System Validation Engineer (CSV)
The Tilburg site offers development and commercial manufacturing of gelatin-based drug delivery dosage forms (soft gels). The site has been a Thermo Fisher Center of Excellence since 1994, offering extensive capabilities for a variety of soft gel technologies, suppling the next generation of medicine for important diseases and supporting the innovation of new consumer products.
In an environment where digitalization and automation of our production processes and quality control unit is a critical initiative, we are looking for a Computerized System Validation Engineer (CSV) to cultivate this transition. The CSV engineer will play a meaningful role in the site transition and will work for a team that has close interaction with our IT organization. Validation team is one of the pillars for the Patheon Softgels BV site, since this group is supporting all validation activities, not only in relation to computerized system but also supporting new product and equipment introduction. Validation team shares pride in leading all validation efforts, delivering project activities on time, and improving our current processes and leading important investments to support the growth of the site.
- The role is within validation team. The senior validation engineer CSV will work closely with manufacturing, IT, supply chain and quality departments.
- The responsibilities consist of performing and/or leading GxP CSV projects in compliance with cGMP, 21 CFR Part 11, GAMP5 and Annex 15. CSV engineer is responsible to ensure that GxP systems meet intended use and align with applicable requirements, current industry practices, and Thermo Fisher Scientific policies and procedures. Validation projects may include manufacturing systems, laboratory systems, facilities systems and steady state activities around these applications. Confirmed knowledge of validation of cGMP automation/computerized systems within an EMA/FDA regulated environment is required and as well, capability to learn and work according to the latest industry standards and the applicable practices for computer validation. Relevant validation experience with Manufacturing and Laboratory systems used within the pharmaceutical industry is necessary for this role.
- Since the individual will also play a key role in our transition process to automate and digitalize our processes and systems, background in project management will be a differentiator. Highly recommended for this role will be the ability to effectively manage numerous projects/priorities and demonstrate excellent written and oral communication skills.
- Given the multitude of projects running within the validation department, sound decision making in time-sensitive and sophisticated situations with good assessment of risk are also skills that are expected.
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 (5-7 years) working in the pharmaceutical industry, preferably in validation. A bachelor or university degree in one of the target areas for the position (e.g. IT, Science or related field) or proven mastering of knowledge and skills required for this position is preferred combined with desire to learn and will to educate in various aspects of computerized system validation is important. The individual should thrive into a matrix organization, managing the complexity of the interface between functional and project organization and balance all priorities.
While there is room in this position to learn and grow experience in all of the different aspects of role and responsibility, there is certainly a benefit in already having a solid background on one or more of the involved areas like validation, GMP and pharmaceutical manufacturing and IT.
Diversity in our organization is an important element to create an effective and challenging working environment. Integrity, Intensity, Innovation and Involvement are basic characteristics that we expect of all members of organization.
A person who enjoys leading change and work within the matrix organization to improve internal processes, with a “can do” mentality will discover happiness in this role.