Validation & Compliance Engineer

PerkinElmer; Canton (OH); On-site; USD 111,000 - 148,000; Full time

Job summary

PerkinElmer's OneSource team in Schachen, Switzerland, is seeking a Validation & Compliance Engineer to review and approve documentation for calibration, maintenance, and repair activities, and to release assets for use. You will manage changes, deviations, CAPAs, and data management within CCMS/CMMS, while ensuring GxP compliance and clear cross-functional collaboration.

The role requires meticulous attention to detail, strong regulatory knowledge, and effective communication with internal and

Qualifications

• Bachelor's degree in Life Sciences or Quality/Compliance required or equivalent.
• Minimum of five years in a (Bio-)Pharma quality, validation or compliance role.
• Knowledge of cGMP, Annex 1, validation regulations and requirements.
• Familiarity with GMP/GLP/GDP and regulatory expectations.

Responsibilities

• Review and approve documents for calibration, maintenance, and repair work.
• Release assets after successful calibration/maintenance.
• Process changes, deviations, and CAPAs related to calibration and maintenance.
• Collaborate with Calibration & Maintenance Engineers to close GDP gaps in docs.
• Contribute to investigations as part of cross-functional teams.

Skills

Attention to detail

Documentation & regulatory knowledge

Communication skills

Team collaboration

Problem solving

Education

Bachelor's degree in Life Sciences or Quality/Compliance

Tools

CCMS/CMMS knowledge

Job description

Validation & Compliance Engineer

Location Schachen, Lucerne CH

Job ID REQ-058082

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!

PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.