QC Equipment/Software Validation Specialist

Devens, Massachusetts
Industry: Biotech / Pharma
Job Number: JN -022021-60274
  • Participate as part of a cross functional global project to qualify QC instruments and associated software.
  • Support the implementations of a new standardized global qualification for QC instrumentation and associated software across five business QC sites.
  • Implement validation strategies for QC instrumentation and associated software, across QC Laboratories.
  • Create, execute and review network led QC instrument/software qualification documents in support of global QC projects such as;
  • Network QC Instrumentation Standardization and Windows 10 upgrades.
  • Deployment of Enterprise Empower3 FR5 to QC sites including re-qualification of associated QC instruments.
  • Author qualification related deviations, identifying root causes and robust CAPAs.
  • Author qualification related change controls and validation plans.
  • Update BMS procedures and documents to implement data integrity controls arising from instrument qualification programs.
  • Serve as liaison with lab-IT teams to harmonise QC instruments software configurations where applicable
  • Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, lifecycle management, and computer system validation.
  • Provide updates on qualification status, project timelines, and escalate challenges as required.
  • Assist Network QC Equipment Lifecycle Lead in schedule development and workload management of project team

Qualifications and Experience required:

  • Minimum of 2 years experience in the pharmaceutical industry. It would be desirable to have at least 1 year experience in laboratory operational role.
  • Demonstrated expertise in large projects within a complex high performance team,
  • Desirable to have at least 1 year of experience in a role either (a) instrument qualification or (b) software validation, with detailed knowledge of regulatory requirements related to QC instruments and associated software
  • Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritise workload with minimum supervision as part of supporting multiple complex projects.
  • Self-directed with a high degree of professional integrity, organization, and attention to detail.
  • Strong interpersonal, oral and written communication skills are essential, including the ability to communicate at all levels with clarity and precision.
  • Ability to work on multiple complex team projects where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
  • Ability to work across timelines and be available to travel when required.
  • Demonstrated use of flexible thinking and growth mind-set is an advantage.


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