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Sr. Computer System Validation Engineer

Location

Durham, NC, USA

Department

IT

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At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, STD, LTD, generous vacation in your first year, sick time, and retirement savings!Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Overview

Cambrex (www.Cambrex.com) is seeking a highly motivated, energetic, results-oriented individual to join our team of dedicated professionals focused on customer service and quality. This role will be responsible for managing and executing GxP CSV projects from project kickoff through system go-live. Project will range in size from simple off the shelf systems to large enterprise systems.

 

This is primarily a remote position that will require periodic onsite visits to support projects activities. Onsite support is estimated to be once a month but will be dependent on project requirements and schedule.

Responsibilities

  • Works closely with project stakeholders (IT, System Owner, QA) to effectively and efficiently implement new systems, system upgrades, or system modifications
  • Develops and manages project schedules to drive efficient projects executions
  • Manages consultants to ensure that project timeline, budget, and quality are maintained
  • Manages CSV projects under a GAMP lifecycle framework
  • Writes, reviews, approves and executes all system lifecycle documents (URS, Validation Plan, Specifications, Risk Assessment, Qualifications IQ/OQ/PQ, Data Integrity Evaluations, Trace Matrix, SOP’s, Validation Summary Report)
  • Conducts data integrity evaluations and enforces the required data integrity controls
  • Supports client and regulatory audit activities
  • Assist in development, implementation, and enforcement of computer system validation and data integrity policies and practices

Qualifications

  • At least 5 years of experience managing and executing Computer System Validation projects in a GAMP framework
  • At least 3 years of project management experience
  • Strong understanding of 21CFR Part 11 and Data Governance/Data Integrity requirements
  • Strong experience with technical writing, risk assessment, gap analysis, change control and deviation management
  • BS/BA