Senior CSV Automation Engineer – Manufacturing

Antler; Juana Díaz (PR); On-site; USD 120,000 - 170,000; Full time

Job summary

Johnson & Johnson is seeking a Staff Automation Engineer, CSV to act as the technical authority for CSV across automated manufacturing systems. This role drives cGMP lifecycle practices, validation execution, and regulatory alignment in support of new product introductions, upgrades, and continuous improvement.

The successful candidate will lead cross-functional teams, coordinate with Quality, IT, and Regulatory partners, and ensure compliance with FDA, 21 CFR Part 11, and data integrity

Qualifications

• Bachelor's degree in Engineering or related field.
• Experience with CSV methodologies in regulated environments.
• Familiarity with GMP/FDA requirements and 21 CFR Part 11.

Responsibilities

• Lead CSV strategies and validation activities for automated manufacturing systems.
• Ensure traceability across URS, IQ/OQ/PQ, and validation deliverables.
• Partner with Quality, IT, and Regulatory to meet FDA and data integrity standards.
• Oversee risk-based validation, audits, and regulatory readiness.
• Provide technical leadership across CSV and system lifecycle activities.

Skills

CSV knowledge

Regulatory leadership

Project management

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related field

Tools

Allen-Bradley PLC

Siemens S7-1500

Beckhoff TwinCAT

HMI/SCADA platforms (Ignition, Wonderware, iFIX, FactoryTalk)

Job description

Johnson & Johnson is seeking a Staff Automation Engineer, CSV to act as the technical authority for CSV across automated manufacturing systems. This role drives cGMP lifecycle practices, validation execution, and regulatory alignment in support of new product introductions, upgrades, and continuous improvement.

The successful candidate will lead cross-functional teams, coordinate with Quality, IT, and Regulatory partners, and ensure compliance with FDA, 21 CFR Part 11, and data integrity