Validation & Compliance Engineer

PerkinElmer's OneSource team is looking for a Validation & Compliance Engineer to support production environment on the Customer site (MSD) in Schachen.

Hybrid working model

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

• Following customer SOPs and regulatory guidelines FDA, EU & SwissMedic