Lead Manufacturing Automation Engineer - Pharmaceutical Manufacturing

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Job Description

Join Capgemini as a Lead Pharmaceutical Manufacturing Automation Engineer to lead and support the design, implementation, validation, and maintenance of automation and OT systems across site operations and projects. This role requires site-level expertise, and will ensure system reliability, regulatory compliance, and effective integration of automation platforms with manufacturing processes across multiple locations in the United States. The position contributes to solution design, troubleshooting, continuous improvement, and documentation, while supporting both engineering and OT functions.

Note: While this role can be remote, travel between sites will be required approximately 50% of the time with visits to Indiana, New Jersey, and California manufacturing sites. As such, the ideal candidate will be situated in a major metro area in or near one of these states.

 

Your role:

Strategy & Org Development

• Support automation/ network technical requests
• Execute change controls & work orders
• Create SOPs & validation/engineering docs

Automation

• Deploy DCS/SCADA/PLC recipes & control logic
• Configure & maintain Historian
• Manage software change controls
• Develop automation solutions meeting manufacturing needs
• Lead troubleshooting & project technical guidance
• Execute engineering tests, changes & documentation per quality
• Drive site automation rollout (cost/schedule/tech)

Operational Technology (OT)

• Operate & maintain OT systems/tools/apps
• Support OT owners & monitor IT/OT events
• Track/audit configuration items
• Execute OT & cybersecurity processes
• Maintain OT asset inventory

Project Engineering & Controls

• Provide validation support; identify solutions
• Create/update specs (URS, config, functional, test)
• Review/approve protocols, deviations, drawings, diagrams, schedules & datasheets
• Perform FAT/SAT & inspections
• Execute project work orders; support commissioning/troubleshooting

(Re-) Qualification

• Perform GMP risk assessments (incl. SRA)
• Create/execute DQ/IQ/OQ
• Troubleshoot during PQ & validation
• Maintain punch lists/task tracking

 

Your skills and experience: 

• 7+ years of experience in pharmaceutical, biotech, or medical device manufacturing environments
• Demonstrable experience with automation engineering, OT engineering, or related disciplines
• Bachelor’s degree in Engineering (Electrical, Automation, Computer, Mechanical, or related field)
• Experience with automation systems including PLCs, SCADA, DCS, HMIs, or control networks
• Experience with regulatory frameworks related to Computerized System Validation (CSV) and Data Integrity (DI) to ensure compliance with FDA, EMA and other regulatory standards
• Familiarity with CSV and Data Integrity requirements in GxP-regulated environments
• Hands-on experience with troubleshooting automation systems, implementing changes, and creating technical documentation
• Understanding of OT systems, cybersecurity concepts, and asset management practices
• Ability to read and interpret engineering drawings and specifications
• Strong analytical and problem‑solving skills
• Effective communication and collaboration abilities

Job Description - Grade Specific

Focus on Manufacturing and Process Engineering. Fully competent in own area. Acts as a key contributor in a more complexor critical environment. Proactively acts to understand and anticipates client needs. Manages costs and profitability for a work area. Manages own agenda to meet agreed targets. Develop plans for projects in own area. Looks beyond the immediate problem to the wider implications. Acts as a facilitator, coach and moves teams forward.

The base compensation range for this role in the posted location is: $125,000 - $166,000

Capgemini provides compensation range information in accordance with applicable national, state, provincial, and local pay