On-Site Automation & CSV Lead: Execution Systems Manager

Biopharma Asia

Wilson (NC)

Sur place

USD 130 000 - 190 000

Plein temps

14 jours+

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Résumé du poste

Johnson & Johnson is seeking an Automation Engineering Manager, Execution Systems CSV Lead, to drive the development of the CSV strategy and ensure full validation across IT, execution and lab systems. This on-site role in Wilson, NC requires deep expertise in DeltaV, Siemens PLCs, and MES (WERUM PAS-X) with strong leadership and regulatory knowledge.

You will partner with Quality, IT, and Operations to align validation plans with global standards, manage lifecycle updates, and deliver

Qualifications

BS Degree in Engineering or related field; required.
Minimum 8 years of experience in a manufacturing environment, preferably biopharma or pharma.
2+ years in Execution Systems, Automation, or IT within pharma/GMP manufacturing.
Deep knowledge of automation hardware and software (DeltaV, Siemens PLCs, OSI PI).
Experience with MES systems (WERUM PAS-X) and DeltaV Batch Control.
Strong understanding of ISA S95/S88 standards.
Familiarity with 21 CFR Part 11 and EU GMP Annex 11.

Responsabilités

Lead the site CSV strategy and execution efforts.
Validate Computerized System Validation for IT, Execution Systems, and Lab systems.
Ensure compliance with global standards and site SOPs.
Collaborate with Quality, IT, Lab Systems, and Procurement.
Track cost, quality, and schedule to ensure successful project delivery.