Staff CSV Automation Engineer — GMP & Regulatory Lead

Johnson & Johnson Innovative Medicine; Añasco (PR); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

401(k) plan

Paid time off

Job summary

Johnson & Johnson Innovative Medicine seeks a Staff Automation Engineer, CSV to lead Computer System Validation across automated manufacturing systems. You will own validation strategies, regulatory alignment, and lifecycle governance, partnering with Quality, IT, and Regulatory teams.

The role requires deep automation expertise, GMP knowledge, and proven leadership in cross-functional projects to ensure data integrity and compliant systems throughout product lifecycles.

Qualifications

• Bachelor’s degree in Engineering, Automation, Robotics, CS or similar.
• GMP/regulated manufacturing experience is required.
• Proven leadership in multidisciplinary automation projects.

Responsibilities

• Serve as CSV technical lead for automated manufacturing systems.
• Define and execute validation strategies for PLC/SCADA and related systems.
• Own system lifecycle from concept through decommissioning per GAMP/J&J.
• Lead risk-based validation and regulatory alignment activities.
• Ensure traceability between URS/FRS/DS/IQ/OQ/PQ/RTM.
• Act as SME during FDA audits and regulatory assessments.
• Lead management of equipment and control systems across facilities.
• Implement regulatory and compliance improvements for cGMP.

Skills

CSV methodologies

GAMP 5

IQ/OQ/PQ

PLC/SCADA expertise

HMI/SCADA development

Regulatory knowledge

Allen-Bradley PLC

Siemens S7

Beckhoff TwinCAT

Education

Bachelor’s degree in Engineering/CS

Tools

Wonderware

Ignition

FactoryTalk View

OPC/Data historian

Job description

Johnson & Johnson Innovative Medicine seeks a Staff Automation Engineer, CSV to lead Computer System Validation across automated manufacturing systems. You will own validation strategies, regulatory alignment, and lifecycle governance, partnering with Quality, IT, and Regulatory teams.

The role requires deep automation expertise, GMP knowledge, and proven leadership in cross-functional projects to ensure data integrity and compliant systems throughout product lifecycles.