Validation Engineer

2 weeks ago


Portsmouth, United States Katalyst HealthCares & Life Sciences Full time
Responsibilities:
  • CSV /Automation experience of 5+ years.
  • Hands on experience in Implementation & Validation of various computerized systems like PCS (DeltaV) / Client (Rockwell) / MES (Syncade) and Pi Historian / SCADA / PLC.
  • Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements.
  • Experienced at working independently as well as in a team-oriented, collaborative environment is essential.
  • Author, Review, Approve and Execute CSV life cycle documentation.
  • Experience working with and programming/commissioning/validating Delta V software platforms.
  • Extensive understanding of 21 CFR Part 11/Annex 11, GAMP 5, and other regulatory guidance associated with computer/automation based systems.
  • Manage, document, and assess the software changes throughout the SDLC following Lonza procedures.
  • Knowledgeable of S88 Batch Standard is preferable.
  • Recipe management DeltaV software development and testing is preferable.
  • MES Recipe authoring and testing is preferable.
  • Implementation and validation of QC system is preferable.
  • Experience with Kneat is preferable.
  • Strong verbal and written communication skills.

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