CSV Execution & Automation Systems Lead

Johnson & Johnson Innovative Medicine

Wilson (NC)

On-site

USD 120,000 - 180,000

Full time

2 days ago

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Job summary

Johnson & Johnson Innovative Medicine is seeking an experienced Automation/CSV leader for on-site work in Wilson, NC. You will drive the Computerized System Validation program, partner with Quality, IT and Operations, and oversee lifecycle management of CSV initiatives across execution systems and ERP interfaces.

The role requires 8+ years in manufacturing with pharma/GMP exposure, expertise with DeltaV, OSI PI, Siemens PLCs, and Werum PAS-X, and strong change-management capabilities to

Qualifications

A minimum BS Degree in Engineering, Science or related field; required.
A minimum of 8 years of manufacturing experience, with at least 2 years in Execution Systems, Automation, or IT in pharma/GMP environments.
Deep knowledge of CSV, cGMP, 21 CFR Part 11 and EU GMP Annex 11.

Responsibilities

Lead the CSV strategy and lifecycle management for the Wilson site.
Ensure compliance with global standards and industry best practices for CSV.
Provide input on SOPs, risk assessments, and validation plans.
Collaborate with Quality, IT, Lab Systems, Procurement and DOTS to optimize processes.
Serve as primary CSV point of contact at the site and track metrics.

Skills

Emerson DeltaV

OSI PI Historian

Siemens PLCs

Werum PAS-X

DeltaV Batch Control

Automation Systems

Change management

GMP/CSV knowledge

Education

BS Degree in Engineering/Science or related field

Tools

Emerson DeltaV

OSI PI

Siemens PLCs

Werum MES/Werum PAS-X

Job description

The role requires 8+ years in manufacturing with pharma/GMP exposure, expertise with DeltaV, OSI PI, Siemens PLCs, and Werum PAS-X, and strong change-management capabilities to

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