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CSV Migration Consultant

CSV Migration Consultant

Katalyst HealthCares & Life SciencesVacaville, CA
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Job Description :

  • Our client is seeking an experienced CSV Migration Consultant to support the implementation, migration, and validation of critical manufacturing systems within a regulated environment.
  • This role requires deep expertise in automation and computerized system validation, particularly with Rockwell and Pharma Suite platforms.
  • The ideal candidate will have a strong background in the full CSV lifecycle, regulatory compliance, and the ability to work in both independent and collaborative settings.

Responsibilities :

  • Lead the implementation, migration, and validation of computerized systems, including PCS (Rockwell / Client), MES (Pharma Suite, POMSnet), and SCADA / PLCs.
  • Apply hands-on expertise in programming, commissioning, and validating Rockwell and Pharma Suite platforms.
  • Author, review, approve, and execute CSV lifecycle documentation in compliance with applicable procedures and industry standards.
  • Ensure adherence to SDLC principles and regulatory requirements, including CFR Part , Annex , GAMP , and Data Integrity guidelines.
  • Manage, document, and assess software changes throughout the SDLC.
  • Collaborate with cross-functional teams to ensure seamless integration and operational excellence.
  • Utilize knowledge of S Batch Standard for batch process design.
  • Perform MES recipe authoring and testing, as well as Rockwell software object development.
  • Support system validation activities using Kneat.

    • Requirements :

  • Experience supporting medium-to-large-scale capital projects in a procurement or expediting function.
  • years of CSV / Automation experience in a regulated environment.
  • Strong, hands-on experience with Rockwell and Pharma Suite (required).
  • Proven track record in implementing and validating PCS, MES, SCADA, and PLC systems.
  • In-depth knowledge of SDLC, CFR Part / Annex , Data Integrity, and GAMP guidelines.
  • Experience with software change management and documentation practices.
  • Familiarity with S Batch Standard, Rockwell software object development, and MES recipe authoring / testing is preferred.
  • Experience with Kneat or other validation management tools is preferred.
  • Excellent verbal and written communication skills.
  • Ability to work independently and collaboratively within a team-oriented environment.
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    Migration Consultant • Vacaville, CA