Manufacturing Asset Specialist

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

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