Manufacturing Asset Specialist

PerkinElmer; Schachen; Hybrid; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

PerkinElmer's OneSource team is seeking a Manufacturing Asset Specialist to support the MSD Customer site in Schachen, Switzerland. The role focuses on document review, asset release, and data management within calibration and maintenance processes.

You will collaborate with calibration and maintenance engineers, handle regulatory documentation, and ensure compliance with cGMP, GMP/GLP, and customer SOPs while working in a hybrid model.

Qualifikationen

• 3–5 years in a Bio-Pharma company in quality, validation or compliance.
• Operator process specialist experience.
• Bachelor’s degree in Life Sciences or Quality/Compliance or equivalent.
• Knowledge of cGMP and validation regulations.
• Knowledge of GMP, GLP, GDocP, pharmacopeia and regulatory requirements.
• Strong English communication; German strongly preferred.
• Customer service mindset.
• Attention to detail and tech-savvy.
• Ability to work independently and in a team; adapt to changing environment.
• Follow customer SOPs and FDA, EU & SwissMedic guidelines.

Aufgaben

• Reviews and approves documents as part of calibration, maintenance, and repair work.
• Collaborate with Calibration & Maintenance Engineers to close GDocP gaps in provided documentation.
• Releases assets after successful calibration, maintenance, and repair work.
• Processes changes, deviations, and CAPA related to calibration and maintenance.
• Contributes to changes and investigations as a member of cross-functional teams.
• Adds, updates, reviews, and releases asset records in CCMS/CMMS databases.
• Reviews and approves administrative release of calibration/maintenance entries in CCMS/CMMS.

Kenntnisse

Quality mindset

cGMP knowledge

GMP/GLP/GDocP knowledge

English communication

German language

Customer service mindset

Attention to detail

Teamwork / adaptability

Regulatory SOP compliance

Independent work

Ausbildung

Bachelor’s degree in Life Sciences or Quality/Compliance

Tools

CCMS/CMMS

Jobbeschreibung

PerkinElmer's OneSource team is looking for a Manufacturing Asset Specialist to support the Team on Customer site (MSD) in Schachen.

MoreinformationaboutPerkinElmer 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!