GxP 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

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