Manufacturing Asset Specialist

PerkinElmer; Lavamünd; Hybrid; EUR 96.000 - 138.000; Vollzeit

Zusammenfassung

PerkinElmer is seeking a Manufacturing Asset Specialist to support a customer site in Schachen, Switzerland. You will review, approve, and release calibration assets and work with engineers to ensure regulatory documentation aligns with GDocP expectations.

The role involves data management in CCMS/CMMS systems and adherence to cGMP standards, with a strong emphasis on accuracy and collaboration across teams.

Qualifikationen

• 3–5 years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles.
• Bachelor's degree in Life Sciences or Quality/Compliance.
• Knowledge of cGMP and validation regulations and requirements.
• Knowledge of GMP, GLP, GDocP, pharmacopeia and regulatory requirements.
• Strong written and verbal communication in English; German preferred.

Aufgaben

• Document Review & Approval / Asset Release - Reviews and approves documents as part of calibration, maintenance, and repair work.
• Collaborate closely with internal and external Calibration & Maintenance Engineers, to close eventual GDocP gaps in provided documentation.
• Releases assets after successful completion of calibration, maintenance, and repair work.
• Processes Changes, deviations, and CAPA related with calibration and maintenance.
• Contributes to changes and investigations as a member of cross-functional teams.
• Data Management / Administrative Release - Adds, updates, reviews, and releases asset records in the customer calibration/maintenance databases (CCMS/CMMS).
• Reviews, approves, and performs administrative release of successful calibration and maintenance entries in Customer CCMS/CMMS systems.

Kenntnisse

English

German

Communication

Attention to detail

Ausbildung

Bachelor's degree in Life Sciences or Quality/Compliance

Tools

CCMS/CMMS

Jobbeschreibung

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

Location(s)

MSD (Switzerland) - Customer Site

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 - Reviews and approves documents as part of calibration, maintenance, and repair work
• Collaborate closely with internal and external Calibration & Maintenance Engineers, to close eventual GDocP gaps in provided documentation
• Releases assets after successful completion of calibration, maintenance, and repair work
• Processes Changes, deviations, and CAPA related with calibration and maintenance
• Contributes to changes and investigations as a member of cross-functional teams
• Data Management / Administrative Release - Adds, updates, reviews, and releases asset records in the customer calibration/maintenance databases (CCMS/CMMS)
• Reviews, approves, and performs administrative release of successful calibration and maintenance entries in Customer CCMS/CMMS systems

Requirements

• 3 to 5 years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles
• Operator process specialist experience
• Bachelor's degree in a Life Sciences or Quality/Compliance discipline or equivalent experience preferred.
• Knowledge of cGMP and validation regulations and requirements
• Knowledge of GMP, GLP, GDocP, pharmacopeia and regulatory requirements preferred.
• Strong written and verbal communication skills in English (required), German (strongly preferred).
• Developed Customer service mindset
• Be passionate in attention to detail and tech aspects
• Ability to work both independently and as a team member, adapt to changing environment
• 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!