When you are part of the team at Thermo Fisher Scientific, you will do important work, and you will be valued and recognized for your performance. With talented managers and inspiring coworkers to support you, you will find the resources and opportunities to make significant contributions to the world.
This position will be responsible for ensuring successful implementation of validation standards as they apply to facilities, utilities, equipment, computer systems, cleaning and processes. Additionally, this role will be responsible for the support of new equipment introduction, technical transfers, requalification and routine activities as they pertain to Manufacturing, Packaging and Warehouse functions, and acting as a customer liaison.
- Review and approve site process validation, packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time and quality to ensure that programs are compliant with inspection agencies requirements and related SOPs.
- Conduct Quality Reviews of validation processes and deliverables to evaluate if they fulfil the requirements for quality, to uncover errors or deficiencies in processes and deliverables.
- To liaise effectively within internal and external functions and provides expert guidance on validation topics.
- Ensures implementation of validation and transfer requirements by providing direction and support for quality / cGMP matters.
- Ensures that the site has a comprehensive Validation Master Plan and that it is properly maintained and followed.
- Follow up of identified validation deviations and escalation to QA management.
- Interface with Quality Assurance and IT partners to ensure that validation practices are aligned with regulatory expectations and best practices.
- Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality of deliverables.
- Coordinate documentation, testing, and change management activities to ensure compliance with business and regulatory needs
- Previous experience in Pharmaceuticals industry
- Bachelor’s degree, preferably in engineering field
- Previous experience in validation is strongly preferred
- Ability to troubleshoot process and equipment issues
- Self-driven, demonstrated ownership & responsibility; Ability to lead, support & motivate a team
- Technical Writing experience
- Professional certifications (ex: CQA) and training (Six Sigma) is a PLUS
- Equivalent combinations of education, training, and relevant work experience may be considered
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.