Validation & Compliance Engineer

PerkinElmer; Schachen; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

PerkinElmer's OneSource team in Schachen, Switzerland seeks a Validation & Compliance Engineer to review and approve calibration, maintenance, and repair documentation, release assets, and manage changes and CAPAs.

You will collaborate with Calibration & Maintenance Engineers to ensure GDP and quality standards and support cross-functional investigations. The role emphasizes attention to detail, strong communication, and ability to work independently within guidelines.

Qualifikationen

• Bachelor’s degree in Life Sciences or Quality/Compliance discipline or equivalent experience preferred.
• Minimum of five (5) years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles
• Knowledge of cGMP, Annex 1 and validation regulations and requirements.
• Knowledge of GMP, GLP, GDP, pharmacopeia and regulatory requirements preferred.
• Developed Customer service mindset
• Be passionate about detail and tech aspects
• Strong written and verbal communication skills.
• Ability to work both independently and as a team member, within prescribed guidelines, coping with frequent grey areas / uncertainty.

Aufgaben

• Reviews and approves documents as part of calibration, maintenance, and repair work
• Collaborate closely with internal and external Calibration & Maintenance Engineers, to close eventual GDP gaps in provided documentation
• Releases assets after successful completion of calibration, maintenance, and repair work
• Processes Changes, Temporary Changes, Deviations, and CAPA related with calibration and maintenance
• Contributes to changes and investigations as a member of cross-functional teams
• Adds, updates, reviews, and releases positions in the Customer calibration/maintenance databases (CCMS/CMMS)
• Reviews, approves, and performs administrative release of successful calibration and maintenance entries in Customer CCMS/CMMS systems

Kenntnisse

Attention to detail

Technical mindset

Team collaboration

Ausbildung

Bachelor’s degree in Life Sciences or Quality/Compliance discipline or equivalent experience preferred.

Jobbeschreibung

PerkinElmer's OneSource team is looking for a Validation & Compliance Engineer to join our team in Schachen, Switzerland. In this role You'll review and approve documentation for calibration, maintenance, and repair activities, release assets for use, and manage changes, deviations, and CAPAs—working closely with Calibration & Maintenance Engineers to keep everything GxP-compliant.

More information about our OneSource services: OneSource Laboratory Solutions | PerkinElmer

Document Review & Approval / Asset Release

• Reviews and approves documents as part of calibration, maintenance, and repair work
• Collaborate closely with internal and external Calibration & Maintenance Engineers, to close eventual GDP gaps in provided documentation
• Releases assets after successful completion of calibration, maintenance, and repair work
• Processes Changes, Temporary Changes, Deviations, and CAPA related with calibration and maintenance
• Contributes to changes and investigations as a member of cross-functional teams

Data Management / Administrative Release

• Adds, updates, reviews, and releases positions in the Customer calibration/maintenance databases (CCMS/CMMS)
• Reviews, approves, and performs administrative release of successful calibration and maintenance entries in Customer CCMS/CMMS systems

Requirements

• Bachelor’s degree in Life Sciences or Quality/Compliance discipline or equivalent experience preferred.
• Minimum of five (5) years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles
• Knowledge of cGMP, Annex 1 and validation regulations and requirements.
• Knowledge of GMP, GLP, GDP, pharmacopeia and regulatory requirements preferred.
• Developed Customer service mindset
• Be passionate about detail and tech aspects
• Strong written and verbal communication skills.
• Ability to work both independently and as a team member, within prescribed guidelines, coping with frequent grey areas / uncertainty.

Join our Team!

We are strongly committed to the development of your career and giving you opportunities to learn and grow. We make a difference for you while you make a difference in the world!