Senior Drug Product Automation Engineering Lead

Johnson & Johnson Innovative Medicine; Wilson (NC); On-site; USD 150,000 - 190,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Wilson, NC, seeks a senior Drug Product automation leader to guide a multi-disciplinary team in designing, delivering, and maintaining highly automated manufacturing processes for sterile products.

You will own the automation strategy, ensure compliance with cGMP and 21 CFR Part 11, partner with Process Engineering, Quality, CSV, and IT, and drive continuous improvement across ISA-95/88 frameworks, MES interfaces, and data integrity initiatives.

Qualifications

• Minimum 8 years of progressive industrial automation experience in pharmaceutical or biopharmaceutical manufacturing.
• Direct ownership for design, implementation, commissioning, qualification, and lifecycle management of automated manufacturing systems.
• Leadership of automation engineers, contractors, system integrators, and suppliers to deliver automation scope.
• Strong knowledge of ISA-95, ISA-88, data integrity, and validation principles.
• Experience with aseptic filling/finish equipment and related automation technologies.

Responsibilities

• Provide end-to-end automation leadership from concept to qualification and handover.
• Define and implement automation strategy, architecture, and lifecycle roadmap.
• Oversee PLC/DCS, SCADA/HMI, batch control, robotics, and interfaces with MES and historians.
• Ensure compliance with cGMP, 21 CFR Part 11, data integrity, and validation.
• Partner with Manufacturing, Process Engineering, Quality, CSV, and OT/IT teams.
• Support inspections, risk assessments, deviations, CAPAs, and lifecycle health.

Skills

Automation leadership

Industrial automation

PLC/SCADA knowledge

cGMP / data integrity

System integration

ISA-95 knowledge

Education

Bachelor's degree in Engineering, Computer Science, or related field

Tools

Emerson DeltaV

Rockwell Automation

Siemens

OSI PI

Werum PAS‑X

Job description

Johnson & Johnson Innovative Medicine in Wilson, NC, seeks a senior Drug Product automation leader to guide a multi-disciplinary team in designing, delivering, and maintaining highly automated manufacturing processes for sterile products.

You will own the automation strategy, ensure compliance with cGMP and 21 CFR Part 11, partner with Process Engineering, Quality, CSV, and IT, and drive continuous improvement across ISA-95/88 frameworks, MES interfaces, and data integrity initiatives.