CSV Engineer

Apply for the CSV Engineer role at Katalyst CRO

This role supports the generation, execution, and documentation of qualification activities for Emerson Delta

V (Client), Siemens PLC, and other GMP automation systems. All validation and qualification deliverables must comply with the client’s global team and site‑specific quality and compliance standards.

• Develop and execute AIOQ protocols (approximately 60) for automation systems including Delta
  
  V, PLC, Client, and L2SS.
• Author and review SOPs and Work Instructions (WIs) related to Client, PLC, Client, and L2SS systems.
• Review and approve vendor Functional Specifications (FS), Design Specifications (DS), and SAT protocols.
• Ensure all qualification testing aligns with approved documentation and Client's compliance guidelines.
• Manage non-conformances, perform impact assessments, and document corrective actions.
• Generate release reports following successful AIOQ execution and resolution of deviations.
• Support ongoing qualification and requalification during equipment operation phases.
• Report progress and issues to the Site CSV Lead and maintain compliance with site change control and validation procedures.

• 510 years of hands‑on CSV experience in Delta
  
  V or other DCS systems.
• Strong working knowledge of GAMP 5, 21 CFR Part 11, and cGMP requirements.
• Experience using KNEAT or equivalent electronic QMS/validation documentation platforms.
• Experience with Siemens PLCs and automation system integration preferred.
• Excellent analytical, documentation, and communication skills.

Mid‑Senior level

Contract

Pharmaceutical Manufacturing