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PerkinElmer

Analytical instruments and software for health

Manufacturing Asset Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeSchächen, SwitzerlandNo salary listed

About the Job

Requirements

  • Three to five years of relevant experience in a biopharmaceutical company in quality, validation, or compliance roles.
  • Operator process specialist experience.
  • Knowledge of current Good Manufacturing Practice (cGMP) and validation regulations and requirements.
  • Strong written and verbal communication skills in English.
  • German language skills are strongly preferred.
  • A customer service mindset.
  • Attention to detail and technical aspects.
  • Ability to work independently and as a team member and adapt to a changing environment.
  • Ability to follow customer standard operating procedures (SOPs) and regulatory guidelines, including those of the U.S. Food and Drug Administration (FDA), the European Union, and Swissmedic.

Responsibilities

  • Review and approve documents as part of calibration, maintenance, and repair work.
  • Collaborate with internal and external Calibration and Maintenance Engineers to close gaps in provided documentation related to Good Documentation Practice (GDocP).
  • Release assets after successful completion of calibration, maintenance, and repair work.
  • Process changes, deviations, and corrective and preventive actions (CAPA) related to calibration and maintenance.
  • Contribute to changes and investigations as a member of cross-functional teams.
  • Add, update, review, and release asset records in customer calibration and maintenance databases (CCMS/CMMS).
  • Review, approve, and perform administrative release of successful calibration and maintenance entries in customer CCMS/CMMS systems.

Desired Qualifications

  • Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Documentation Practice (GDocP), pharmacopeia, and regulatory requirements.
  • Bachelor’s degree in a Life Sciences or Quality/Compliance discipline, or equivalent experience.

About the Company

PerkinElmer

Analytical instruments and software for health

PerkinElmer provides analytical instruments, software, and services for the life sciences, diagnostics, and environmental health markets. Customers use these tools to collect and analyze data through a combination of hardware, consumable supplies, and software licensing. Unlike many competitors, the company integrates a global service network with a focus on sustainability by designing products that reduce waste and energy consumption. Its goal is to improve human and environmental health by helping laboratories and industrial companies achieve more efficient and accurate scientific results.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Shelton, CT
Founded
1937

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