DirectJobHub
Jobs · Information Technology · New Hampshire

Senior Computer Systems Validation Specialist

TekWissen ® · Portsmouth, NH · 2 wk ago
On-siteInformation Technology$45–$55/hrContract

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence to help deliver new and innovative medicines for a wide range of diseases. The company specializes in pharmaceutical ingredients, bioscience, biopharmaceuticals, custom manufacturing, biotechnology, life science ingredients, nutrition, microbial control, agriculture, materials science, personal care, and cell and gene therapy.

Location: Portsmouth, NH 03801
Duration: 6 Months
Work Type: Onsite, 1st Shift
Pay Rate: $45 to $55 per hour, flexible depending on experience

About the Role

The Senior Computer Systems Validation Specialist (CSV Specialist Level 3) helps lead team members in assessing new and changing computerized systems to ensure compliance with company policies, procedures, and industry guidance. The role is responsible for risk assessing systems, reviewing change requests and test scripts, drafting protocols, initiating and reviewing GMP documentation revisions, and providing guidance to junior team members. The specialist also serves as the QA CSV representative for both small and large-scale projects.

Responsibilities

  • Perform all aspects of QMS processes, including Change Control, Deviations, and CAPAs.
  • Execute all responsibilities as CSV Project Lead for simple projects.
  • Oversee and perform all CSV qualification activities for DeltaV and Syncade systems.
  • Perform validation maintenance of computerized systems.
  • Review and revise CSV SOPs.
  • Review engineering documents, including P&IDs, SOPs, Specifications, and Submittals.
  • Assist with audits and inspections.
  • Perform other duties as assigned.
  • Adhere to cGMP requirements during the manufacture of drug products.
  • Notify responsible management in a timely manner of serious GMP deficiencies, process deviations, product defects, and related actions.
  • Follow job safety procedures and attend required health and safety training.
  • Proactively promote workplace safety and promptly report actual and potential accidents and injuries.
  • Comply with company and site safety policies.

Requirements

  • Bachelor’s Degree in Computer Science, Software Engineering, or a related field.
  • Experience in validating DeltaV and Syncade systems, as well as Spreadsheets and SharePoint.
  • Experience with 21 CFR Part 11 and ISPE GAMP guidelines related to Computer Systems Validation (CSV).
  • Experience with QMS processes, including Change Control, Deviations, and CAPAs.
  • Experience performing CSV qualification activities for DeltaV and Syncade systems.
  • Experience with validation maintenance of computerized systems.
  • Ability to review and revise CSV SOPs.
  • Experience reviewing engineering documents such as P&IDs, SOPs, Specifications, and Submittals.
  • Strong written and oral communication skills.
  • Strong organizational and time management skills.

Similar jobs