Validation & Compliance Engineer

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs.  With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.

Job Title

Validation & Compliance Engineer

Location(s)

MSD (Switzerland) - Customer Site

Job Description

PerkinElmer's OneSource team is looking for a Validation & 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!