Validation & Compliance Engineer

Perkin Elmer's One Source team is looking for a Validation & Compliance Engineer to support production environment on the Customer site (MSD) in Schachen. More information about Perkin Elmer and our business :
Perkin Elmer | Science with Purpose More information about our One Source services:
One Source Laboratory Solutions | Perkin Elmer Hybrid working model

• 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.

• 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 & Swiss Medic

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