Automation CSV Lead – Execution Systems

Johnson & Johnson Innovative Medicine

Kansas

On-site

USD 120,000 - 180,000

Full time

14 days+

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Job summary

Johnson & Johnson Innovative Medicine seeks an Automation Engineering Manager to lead Execution Systems CSV, driving validated, compliant automation across IT, process, and analytics. Based in Wilson, NC, you will partner with Quality, IT, and Operations to deliver critical lifecycle projects.

You will oversee validation activities and ensure alignment with global standards and 21 CFR Part 11/EU Annex 11, guiding a skilled CSV team to successful delivery.

Qualifications

Minimum BS degree in Engineering, Science or related field.
At least 8 years of manufacturing experience, with 2+ in Execution Systems/Automation within pharma or GMP manufacturing.
Deep knowledge of CSV, cGMP regulations, and validation practices (21 CFR Part 11, EU GMP Annex 11).
Experience with MES, DeltaV, and IT/infrastructure in regulated environments.

Responsibilities

Lead CSV strategy development and lifecycle management at the site and globally.
Coordinate validation activities for IT, Execution Systems, and Laboratory Analytics.
Ensure compliance with global standards and regulatory expectations.
Develop and monitor KPI and risk assessments; drive continuous improvement.

Skills

8+ years manufacturing experience

Execution Systems

Automation

IT in pharma

Emerson DeltaV

OSI PI

Siemens PLCs

Werum PAS-X

DeltaV Batch Control

ISA S95

ISA S88

cGMP CSV

21 CFR Part 11

EU GMP Annex 11

OSI PI Historian

Werum MES

Change management

Education

BS Degree in Engineering or related field

Tools

Werum PAS-X

DeltaV

OSI PI Historian

Siemens PLCs

Job description

You will oversee validation activities and ensure alignment with global standards and 21 CFR Part 11/EU Annex 11, guiding a skilled CSV team to successful delivery.

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