CSV Automation Lead: Execution Systems

NCBiotech

Wilson (NC)

On-site

USD 130,000 - 170,000

Full time

9 days ago

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Job summary

Johnson & Johnson seeks an experienced Automation Engineering Manager, Execution Systems CSV, to drive the site CSV strategy and lifecycle management. You will lead validation efforts across IT, execution systems, and lab systems, ensuring compliance with global standards and regulatory requirements.

The role requires 8+ years in manufacturing with pharma/GMP exposure, expertise in DeltaV, OSI PI, and Werum PAS-X, and strong leadership for cross-functional teams and continuous improvement.

Qualifications

BS degree in Engineering, Science or related field required.
8+ years in manufacturing, with 2+ years in Execution Systems/Automation/IT in pharma or GMP setting.
Deep knowledge of automation systems (DeltaV, PI Historian, Werum PAS-X).
Familiarity with cGMP, 21 CFR Part 11 and EU GMP Annex 11.
Strong ISA S95/S88 framework experience and change control practices.

Responsibilities

Lead CSV strategy delivery and lifecycle management at site.
Validate and ensure compliance of IT, Execution Systems, and Laboratory Analytical systems.
Coordinate with Quality, IT, Lab Systems, Procurement for cross-functional alignment.
Develop and monitor metrics and KPIs; manage project resourcing and costs.

Skills

Automation systems

CSV knowledge

cGMP & 21 CFR Part 11

ISA S95/S88

Change management

Execution Systems

IT infrastructure

DeltaV

MES systems

Education

BS degree in Engineering or related field

Tools

Emerson DeltaV

OSI PI Historian

Werum PAS-X

Siemens PLCs

Job description

The role requires 8+ years in manufacturing with pharma/GMP exposure, expertise in DeltaV, OSI PI, and Werum PAS-X, and strong leadership for cross-functional teams and continuous improvement.

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