Manufacturing Asset Specialist — Calibration & Release

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 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.