Senior CQV Engineer — Thermo Fisher Scientific (Schweiz) AG
CHF 94'500 - 143'000
Thermo Fisher Scientific (Schweiz) AG · Lengnau, Switzerland (BE)
- Location
- Lengnau
- Contract
- full-time
- Posted
- 31 days ago
SalaryCHF 94'500 - 143'000
Role overview
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!
- 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
- Prepares, reviews and approves production, validation, audit reports documents, procedures, and rationales
- Evaluates new regulations, changes to existing regulations and regulatory trends
Main responsibilities
- 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 Requirements
Application process
- 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)
- If you are driven and excited to support our mission, we would love to hear from you.
- today and take the next step in your career with Thermo Fisher Scientific Inc.!
Additional details
- 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.)
- 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
- Works in a safe and responsible manner in order to build an injury-free and incident-free workplace Participates in calibration activities
- Apply today and take the next step in your career with Thermo Fisher Scientific Inc.!
Notes and original content
- Work Schedule
- Standard Office Hours (40/wk)
- Environmental Conditions
- Job Description
- Responsibilities
- Works in a safe and responsible manner in order to build an injury-free and incident-free workplace
- Participates in calibration activities
- Requirements
