Validation Engineer II

SGS_JOB_3213

Scientific
 New Hampshire
CSV
Deltav

Contract - 7 Months

Location : Portsmouth NH Validation Engineer II responsible for Computer System Validation (CSV) in a regulated biotech/pharma manufacturing environment, ensuring GMP compliance for automation, process control, and MES systems while supporting site and process improvement initiatives.

Job Responsibilities:

  • Own CSV activities for equipment, automation, and computer systems
  • Perform risk assessments, review change requests, and validate test scripts
  • Draft and execute validation protocols and manage GMP documentation updates
  • Lead Change Control, Deviations, and CAPAs within the QMS
  • Support and validate DCS (DeltaV) and MES (Syncade) systems
  • Collaborate with cross-functional teams to improve validation efficiency and compliance

Skills:

  • Computer System Validation (CSV) in GMP environments
  • Process Control Systems & Automation
  • DeltaV DCS (preferred) and MES (Syncade)
  • Biotech/Pharma or biologics manufacturing experience
  • QMS processes (Change Control, Deviations, CAPA)

Education/Experience:

  • Bachelor's.

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