Job Description

QC Instrument and Software Validation Specialist
Job Number: 21-02023
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QC Instrument and Software Validation Specialist for our client in Devens, MA
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
  • 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 Client QC sites.
  • Implement validation strategies for QC instrumentation and associated software, across Client 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 requalification of associated QC instruments.
  • 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 programmes.
  • Serve as liaison with lab-IT teams to harmonise 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

  • 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.
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Paul Quibuyen

Paul Quibuyen | LinkedIn

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status

Application Instructions

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