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 support production environment 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

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!

Responsibilities

Performs the review and validation of test and data analysis equipment and systems used for phase 1 and phase 2 manufacturing.; Maintains all documentation pertaining to maintenance and qualification/calibration, both original and electronic records into Customer systems.; May contribute to developing procedures and/or protocols.; Serves as information resource for validation technicians, contractors and vendors.; Contribute with Customer QA and Technical Unit in developing and implementing new specifications.; Contribute to change management and deviation tracking processes, including leading or contributing to CAPA.

Requirements

Bachelor’s degree in Life Sciences or Quality/Compliance discipline or equivalent experience preferred.; 3 to 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, GDocP, pharmacopeia and regulatory requirements preferred.; Developed Customer service mindset; Be passionate about 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; F ollowing customer SOPs and regulatory guidelines FDA, EU & SwissMedic