Validation & Compliance Engineer
Description
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
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Location(s)
MSD (Switzerland) - Customer Site
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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
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Performs the review and validation of test and data analysis equipment and systems used for phase 1 and phase 2 manufacturing.
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Maintains all documentation pertaining to maintenance and qualification/calibration, both original and electronic records into Customer systems.
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May contribute to developing procedures and/or protocols.
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Serves as information resource for validation technicians, contractors and vendors.
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Contribute with Customer QA and Technical Unit in developing and implementing new specifications.
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Contribute to change management and deviation tracking processes, including leading or contributing to CAPA.
Requirements
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Bachelor’s degree in Life Sciences or Quality/Compliance discipline or equivalent experience preferred.
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3 to 5 years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles
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Knowledge of cGMP, Annex 1 and validation regulations and requirements.
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Knowledge of GMP, GLP, GDocP, pharmacopeia and regulatory requirements preferred.
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Developed Customer service mindset
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Be passionate about detail and tech aspects
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Strong written and verbal communication skills in English, German language knowledge will be beneficial.
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Ability to work both independently and as a team member
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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!