Senior CQV Engineer
Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Join Thermo Fisher Scientific Inc. as a Sr CQV Engineer and become part of a great team in Switzerland! This is an outstanding opportunity to work with a world\-class company committed to making the world healthier, cleaner, and safer. We value collaboration and innovation, and we are excited to welcome an experienced individual who shares our dedication to excellence.
Responsibilities
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- Prepares, reviews and approves production, validation, audit reports documents, procedures, and rationales
- Evaluates new regulations, changes to existing regulations and regulatory trends; prepares inspections and customer audit responses and reports; performs gap analysis to resolve efficiencies and take appropriate actions
- Defines, in collaboration with other partners (Quality Assurance, System Owner…) the requalification strategy of GMP systems and implements it, including maintaining the quality system and complete practical activities
- Coordinates execution of activities by external contractors
- Performs requalification and revalidation Work Orders, including routine and non\-routine operations, and documents in forms and OMX following Good Documentation Practices
- Participates in the culture of continuous improvement and development of technologies
- Identifies training needs and develop training programs.
- Works in a safe and responsible manner in order to build an injury\-free and incident\-free workplace
- Participates in calibration activities
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- Bachelor’s degree in Biotechnology, Quality, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related field \+ 10 years experience
- Or Master's degree \+ 3 years in the engineering field, preferably in the pharmaceutical, or chemical process industry
- Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility
- Experience in the pharmaceutical industry for qualification \& validation is required
- Experience of multi\-cultural work environment
- Excellent verbal and written communication skills in English and preferably German or another European language
- Strong understanding of GMP standards and regulatory requirements
- Excellent technical writing skills with attention to detail
- Proficiency in PC applications, including MS Office
- Strong communication and interpersonal skills
- Certification in technical writing or quality management
- Experience with electronic documentation management systems (e.g., Documentum, TrackWise)
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