von: PerkinElmer
Validation Compliance Engineer
PerkinElmer’s OneSource team is looking for a Validation Compliance Engineer to support bproduction environment on the Customer site (MSD) in Schachen.
More information about PerkinElmer and our business : PerkinElmer | Science with Purpose (opens in new window)
More information about our OneSource services: OneSource Laboratory Solutions | PerkinElmer (opens in new window)
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!
Validation & Compliance Engineer in Lucerne Arbeitgeber: PerkinElmer
Als Arbeitgeber bieten wir Ihnen ein flexibles hybrides Arbeitsmodell mit minimalen Vor-Ort-Anforderungen, das Ihnen die Möglichkeit gibt, Ihre Arbeitsweise selbst zu gestalten. In dieser abwechslungsreichen Rolle als Business Administrator haben Sie die Chance, echte Verantwortung zu übernehmen und operative Prozesse aktiv zu gestalten und zu verbessern. Unsere kollaborative und funktionsübergreifende Arbeitsumgebung fördert nicht nur den Austausch von Ideen, sondern auch Ihre persönliche und berufliche Weiterentwicklung.
