Lead Manufacturing Automation Engineer - Pharmaceutical Manufacturing
About The Position
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.
Requirements
- 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
Responsibilities
- Support automation/ network technical requests
- Execute change controls & work orders
- Create SOPs & validation/engineering docs
- 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)
- 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
- 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
- Perform GMP risk assessments (incl. SRA)
- Create/execute DQ/IQ/OQ
- Troubleshoot during PQ & validation
- Maintain punch lists/task tracking
Benefits
- Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
- Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
- Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
- Life and disability insurance
- Employee assistance programs
- Other benefits as provided by local policy and eligibility
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
