Manufacturing Asset Specialist

PerkinElmer; Canton (OH); Hybrid; USD 110,000 - 159,000; Full time

Job summary

PerkinElmer in Lucerne, Switzerland, is seeking a Manufacturing Asset Specialist to support calibration, maintenance, and asset release on customer sites. Hybrid working model and close collaboration with Calibration & Maintenance Engineers help ensure documentation quality and compliance.

The role requires 3–5 years in a (Bio-)Pharma environment focusing on quality, validation or regulatory compliance, with strong English communications and a customer-service mindset.

Qualifications

• 3 to 5 years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles.
• Operator process specialist experience.
• Knowledge of cGMP and validation regulations.
• Knowledge of GMP, GLP, GDocP, pharmacopeia and regulatory requirements.
• Strong written and verbal communication skills in English (required), German (strongly preferred).
• Developed Customer service mindset.
• Attention to detail and tech aptitude.
• Ability to work both independently and as a team member, adapt to changing environment.
• Following customer SOPs and regulatory guidelines FDA, EU & SwissMedic.

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.

Skills

Quality compliance

Regulatory awareness

English communication

Team collaboration

Attention to detail

Education

Bachelor’s degree in Life Sciences or Quality/Compliance

Job description

Manufacturing Asset Specialist

Job ID: REQ-058080

Location: Schachen, Entlebuch District, Canton of Lucerne

Job Type: Regular

PerkinElmer's OneSource team is looking for aManufacturing 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!