Manager, Laboratory Equipment Qualification & Validation

Manager, Laboratory Equipment Qualification & Validation

Moderna

Madrid, Spain

The Role:

The individual in this role will manage laboratory equipment lifecycle on behalf of Moderna AS&T/QC Lead team Madrid Site, coordinating new installation qualification, periodic ordinary and extraordinary maintenance and requalification activities for all (AS&T and QC) instruments in use in Madrid Lab, guarantying business continuity and proper governance of AS&T/QC equipment lifecycle. The individual will coordinate across multi-discipline teams (including external service providers) to meet business objectives and may support Investigations for Quality Events.

Here’s What You’ll Do:

As part of the QC team, your primary responsibilities will be as follows:

  • Coordinate Laboratory equipment installation and qualification activities during the first months of operation of new Moderna Lab in Madrid
  • Interact daily and coordinate external service providers in charge for equipment installation and qualification
  • Monitor and communicate Instrument lifecycle (asset induction, move/decommission, CQV activities, etc.) timelines using project management tools
  • Serve as the point person in QC for all equipment inquiries and relay to appropriate vendors as well as onsite support
  • Support equipment needs of AS&T/QC laboratory including the Microbiology, Bioassay, Chemistry and Sample management departments
  • Manage and own quality systems records related to Laboratory equipment such as deviations, change controls, CAPAs from start to finish
  • Support efforts for method troubleshooting, remediation, change, and optimization efforts in cross functional teams
  • Author, update, and maintain Equipment/Instrument inventory, master file and SOPs
  • Perform data entry, analysis, trending and review using electronic/paper systems
  • Other responsibilities include supporting team projects and proactive initiatives

Here’s What You’ll Bring to the Table:

  • Minimum education required: Bachelor’s degree in relevant sciences and 10 years of industry experience in a cGMP laboratory setting. Level determined by experience.
  • Strong technical background in Chemical, Microbiology or Analytical Instrumentation/Software, method acquisition and instrument troubleshooting.
  • Demonstrate ability to problem solve, organize, and see-through project timelines independently.
  • Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.
  • Strong technical writing skills, oral communication and organizational skills.
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Spain     Manager and Executive     Manufacturing and Logistics     Quality Assurance     Moderna    

© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2022

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies