Katalyst CRO
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CSV Engineer
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Katalyst CRO
This role supports the generation, execution, and documentation of qualification activities for Emerson DeltaV (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.
Responsibilities
Develop and execute AIOQ protocols (approximately 60) for automation systems including DeltaV, 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.
Requirements
510 years of hands‑on CSV experience in DeltaV 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.
Seniority Level Mid‑Senior level
Employment type Contract
Job function Pharmaceutical Manufacturing
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CSV Engineer
role at
Katalyst CRO
This role supports the generation, execution, and documentation of qualification activities for Emerson DeltaV (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.
Responsibilities
Develop and execute AIOQ protocols (approximately 60) for automation systems including DeltaV, 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.
Requirements
510 years of hands‑on CSV experience in DeltaV 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.
Seniority Level Mid‑Senior level
Employment type Contract
Job function Pharmaceutical Manufacturing
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