Lab Instrument Qualification Support

LAB INSTRUMENT QUALIFICATION SUPPORT DEVENS, MA Required Skills:

• Bachelor's degree in relevant scientific or computer area with 3 - 5 years' experience in the biopharmaceutical industry or MS degree with 2 years' experience or equivalent combination of education and experience.
• Minimum 2 years' 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 expertise in large projects.
• Demonstrated ability to work independently as well as contribute to a team based collaborative environment and prioritize 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 travel when required.

• Participate as part of a cross functional global project to qualify QC instruments and associated software.
• 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 requalification of associated QC instruments.
• Support the implementations of a new standardized global qualification for QC instrumentation and associated software across five Client QC sites.
• Implement validation strategies for QC instrumentation and associated software, across Client QC Laboratories.
• Author qualification related deviations, identifying root causes and robust CAPAs.
• Author qualification related change controls and validation plans.
• Update Client procedures and documents to implement data integrity controls arising from instrument qualification programs.
• Serve as liaison with lab-IT teams to harmonize QC instrument's 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.