Validation & Compliance Engineer at PerkinElmer, MSD (Switzerland) - Customer Site
Validation & Compliance Engineer at PerkinElmer in MSD (Switzerland) - Customer Site. Full-time. Apply with swipeandhired.
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
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
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!