GxP 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 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.