Job Description

Analytical Instrument Computer System Validation (CSV) Technical Lead
Job Number: 21-06812
 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for an Analytical Instrument Computer System Validation (CSV) Technical Lead 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!
 
Responsibilities:
  • Develop CSV testing strategies for qualification of the upgraded QC instrument's software and associated interfaces (e.g. Nugensis and File Transfer to LES)
  • Manage the day to day activities associated with upgrading of instruments to operate with Windows10 software, developing plans and schedules for the NQC team to execute in order to meet project deliverables
  • Collaborating with IT business partners to develop software configurations in order to meet regulatory and Client Data Integrity requirements
  • Collaborating with IT define data migration solutions and testing plans for system upgrades to Windows 10 compatible software
  • Collaborate/liaise with cross functional teams, such as QA, IT, and site QC instrument groups to ensure validation activities completed on schedule to ensure timely release for use in QC
  • Provide Technical SME Review and Approval of qualification documents, ensuring compliance with corporate policies, directives and current regulatory requirements for laboratory instruments, including Data Integrity requirements
  • Technical Approval qualification related deviations, ensuring root cause identified and ensuring robust CAPAs Plans defined
  • Report on qualification status, project timelines, and escalate challenges as appropriate to Network QC Management
  • Support the Network leadership team in developing & implementing a strategy to standardize QC instruments (make/model/software) and data reporting in order to reduce Data Integrity (DI) risks
 
Qualifications:
  • Capable of independent workload management across multiple project teams
  • Minimum of 7 years' experience in the pharmaceutical industry with minimum of 5 years' experience within Computer System Validation (CSV). Experience with Analytical Instrument software validation
  • Expert Knowledge of regulatory requirements (e.g. 21CFR part 11, EU annex 11) data integrity (e.g. GAMP5, MHRA, FDA, WHO, PIC/S)
  • Knowledge of GxP industry standards and regulatory guidance related to analytical instrument qualification and data integrity (e.g. USP 1058, GAMP5, MHRA, FDA, WHO, PIC/S)
  • Demonstrated experience (>2 years) in leading CSV activities, with proven track record of on-time delivery
  • Experience with data migration concepts
  • Able to manage schedules and organise meetings across multiple teams/sites
  • Working knowledge of MS Project, MS teams, Microsoft Word, Power Point and Excel
  • 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 with advanced notice
  • Demonstrated use of critical thinking skills and growth mind-set
 
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:
Jay Lucas
arjay.lucas@eclaro.com
6463571240
Jay Lucas | 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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