• Author equipment qualification/validation protocols for the QCL.
  • Technical review and execution of qualification/validation protocols.
  • Recommend and specify equipment purchases based on user requirements.
  • Communicate with other functions and external vendors regarding qualification, maintenance issues, and key operational objectives.
  • Act as liaison between the building scheduler, maintenance shops and lab personnel to schedule preventative and corrective maintenance of equipment.
  • Responsible for design and execution of laboratory CSV initiatives and deliverables, System Security Administrator duties, system upgrades, and data integrity.
  • Apply knowledge of quality principles, GMPs, federal regulations, corporate standards and practices and local procedures in the development of qualification/validation protocols and equipment lifecycle management.
  • Interact effectively with customers, support groups and development.
  • Network with other areas to understand best practices, share knowledge, participate in global meetings and web seminars, and to ensure customer needs are met.
  • Influence improvements and streamline quality systems relating to equipment.
  • Serve as equipment expert and technical resource in the review of technical documents.
  • Act as subject matter experts and originator of change controls.
  • Originate and investigate TrackWise CAPA records.
  • Interact with Global Quality Lab Equipment function to set global corporate policy regarding equipment.
  • Ability to multitask, prioritize and coordinate work to meet customers needs.
  • Demonstrate problem solving and investigative skills.
  • Ability to make decisions based on knowledge, experience, best practices and requirements.
  • Ability to work independently and accurately with minimal supervision.
Basic Requirements:
  • Bachelor degree in scientific field related to the lab (Chemistry/Biology/Microbiology/Engineering)
  • At least 3 years laboratory experience in QC or development lab and/or providing substantial support for equipment and/or systems in a in a GMP environment
Additional Skills/Preferences
  • Ability to work 8 hour days – Monday through Friday
  • Ability to work overtime as required.
  • Ability to carry cell phone off shift and respond to operational issues as required.
  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
  • Working knowledge of CMMS, SmartLab, TrackWise, Quality Docs/Veeva Vault.
Additional Information:
  • Minimal travel required.
  • Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position.

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