Manufacturing Asset Specialist
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
Manufacturing Asset Specialist
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Location(s)
MSD (Switzerland) - Customer Site
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Job Description
PerkinElmer's OneSource team is looking for a Manufacturing Asset Specialist to support the Team on 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
Document Review & Approval / Asset Release
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Reviews and approves documents as part of calibration, maintenance, and repair work
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Collaborate closely with internal and external Calibration & Maintenance Engineers, to close eventual GDocP gaps in provided documentation
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Releases assets after successful completion of calibration, maintenance, and repair work
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Processes Changes, deviations, and CAPA related with calibration and maintenance
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Contributes to changes and investigations as a member of cross-functional teams
Data Management / Administrative Release
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Adds, updates, reviews, and releases asset records in the customer calibration/maintenance databases (CCMS/CMMS)
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Reviews, approves, and performs administrative release of successful calibration and maintenance entries in Customer CCMS/CMMS systems
Requirements
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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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Operator process specialist experience
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Bachelor’s degree in a Life Sciences or Quality/Compliance discipline or equivalent experience preferred.
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Knowledge of cGMP and validation regulations and requirements
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Knowledge of GMP, GLP, GDocP, pharmacopeia and regulatory requirements preferred.
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Strong written and verbal communication skills in English (required), German (strongly preferred).
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Developed Customer service mindset
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Be passionate in attention to detail and tech aspects
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Ability to work both independently and as a team member, adapt to changing environment
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Following 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!