Validation & Compliance Engineer

PerkinElmer Scientific (Switzerland) GmbH seeks a Validation & Compliance Engineer in Schachen to manage documentation and asset release for calibration and maintenance within the OneSource team.

Operating within the OneSource team, this position focuses on ensuring the integrity of calibration, maintenance, and repair workflows. The engineer is responsible for documenting these activities, closing gaps in Good Distribution Practice (GDP) compliance, and formally releasing assets once work is successfully completed.

Responsibilities

• Evaluate and authorize documentation associated with calibration, maintenance, and repair activities.
• Partner with Calibration & Maintenance Engineers to resolve documentation gaps related to GDP standards.
• Execute the release of assets following the successful conclusion of calibration, maintenance, or repair tasks.
• Manage Change orders, Temporary Changes, Deviations, and Corrective and Preventive Actions (CAPA) linked to calibration and maintenance processes.
• Participate in cross-functional teams to support investigations and process changes.
• Input, modify, review, and publish equipment positions within Customer Calibration/Maintenance Management Systems (CCMS/CMMS).
• Conduct administrative reviews and approvals for calibration and maintenance records within CCMS/CMMS platforms.

Requirements

• Hold a Bachelor’s degree in Life Sciences, Quality, or Compliance, or possess equivalent professional experience.
• Demonstrate at least five years of relevant experience in quality, validation, or compliance roles within the (Bio-)Pharma industry.
• Possess working knowledge of cGMP, Annex 1, and general validation regulations.
• Exhibit strong written and verbal communication abilities.
• Work effectively both independently and collaboratively, navigating ambiguous situations and adhering to established guidelines.

Nice to have

• Familiarity with GMP, GLP, GDP, pharmacopeia standards, and broader regulatory requirements.
• A strong customer service orientation.
• A keen passion for technical details and precision.

What the company offers

• Access to career development programs and opportunities for professional growth.

About the company

PerkinElmer Scientific (Switzerland) GmbH strives to create positive impacts for its workforce while simultaneously contributing to broader societal and environmental well-being.

• Focus on making a difference for employees.
• Commitment to making a positive impact in the world.