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Our client is looking for a
Qualification Engineer (m/f/d) 100%
to complement his team.
Form of employment: Temporary position for 12 to18 months
Place of work: Neuchâtel region
Salary range: by agreement
Starting date: by agreement
Specific responsibilities of the Qualification and Validation Engineer include, but are not limited to, the following:
- Support/conduct FAT/SAT and then IQ/OQ/PQ validation studies of equipment and processes utilities and software validations
- Advise project teams
- develop/review and approve validation protocols and final reports
- Manage Change Control on material specifications and documentation
- develop and validate test method validation (Gage R&R)
- Support of continuous improvement on process and on Qualification and Validations project
- Support on Non Conformity, CAPA, Internal audits and failure investigations
- Participate in project planning, scheduling, and tracking
- Develop and implement procedures to comply with corporate and industry standards
- Provide validation training to Operations employees
- At least 5 years of experience in Quality or Validation Engineering.
- BSc, MSc or PhD in Engineering or related field.
- Applied knowledge of FDA and international Pharmaceutical and or medical device regulations is preferred
- Applied knowledge of the application of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), SPC, Root Cause Analysis, etc.
- Applied technical understanding of manufacturing equipment; processes specific to pharmaceutical and or medical device manufacturing preferred
- Demonstrated problem solving and troubleshooting skills
- Demonstrated effective verbal and written communication skills