Validation & Compliance Engineer

PerkinElmer's OneSource team is looking for aValidation & Compliance Engineer to join the team on the Customer site (MSD) in Schachen.

More information about PerkinElmer and our business : PerkinElmer | Science with Purpose

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

Hybrid working model

Responsibilities:

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 GDocP gaps in provided documentation
• Releases assets after successful completion of calibration, maintenance, and repair work
• Processes 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 asset records 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

• 3 to 5 years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles
• Expert in CCMS/CMMS
• Operator process specialist experience
• Bachelor’s degree in a Life Sciences or Quality/Compliance discipline or equivalent experience preferred.
• Knowledge of cGMP and validation regulations and requirements
• Knowledge of GMP, GLP, GDocP, pharmacopeia and regulatory requirements preferred.
• Developed Customer service mindset
• Be passionate in attention to detail and tech aspects
• Strong written and verbal communication skills in English, German language knowledge will be beneficial.
• Ability to work both independently and as a team member, adapt to changing environment
• Following customer SOPs and regulatory guidelines FDA, EU & SwissMedic

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!