Manufacturing Asset Specialist

PerkinElmer; Luzern; Hybrid; CHF 90.000 - 135.000; Vollzeit

Zusammenfassung

PerkinElmer is seeking a Manufacturing Asset Specialist to support the OneSource team on customer sites in Schachen, Lucerne. This hybrid role focuses on calibration, maintenance, and asset release, working with Calibration & Maintenance Engineers to close GDocP gaps and ensure compliant documentation.

You will manage asset records in CCMS/CMMS, review calibration entries, and handle changes, deviations, and CAPA as part of cross-functional teams.

Qualifikationen

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

Aufgaben

• 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
• 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

Quality/Compliance

GxP knowledge

Customer service mindset

Attention to detail

Team player

English fluent

German preferred

Ausbildung

Bachelor's degree Life Sciences

Bachelor's degree Quality/Compliance

Jobbeschreibung

Manufacturing Asset Specialist

Job ID: REQ-058080

Location: Schachen, Entlebuch District, Canton of Lucerne

Job Type: Regular

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 (opens in new window)

More information about our OneSource services: OneSource Laboratory Solutions | PerkinElmer (opens in new window)

Hybrid working model

Responsibilities:

• 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!