CSV Engineer

Katalyst Healthcares and Life Sciences

Elm City, NC

Job Description:

The CSV Engineer will support the generation, execution, and documentation of qualification activities for Emerson DeltaV (Client), Siemens PLC, and other GMP automation systems.
This role ensures all validation and qualification deliverables 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.
uthor 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:

5-10 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.

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Vacancy posted 5 days ago

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