Capgemini · 18 hours ago
Lead Manufacturing Automation Engineer - Pharmaceutical Manufacturing
Capgemini is a global business and technology transformation partner, and they are seeking 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 to ensure system reliability, regulatory compliance, and effective integration of automation platforms with manufacturing processes across multiple locations in the United States.
ConsultingInformation TechnologyInsurTechIT ManagementSoftware
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
Qualification
Required
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
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
Company
Capgemini
Capgemini is a software company that provides consulting, technology, and digital transformation services.
H1B Sponsorship
Capgemini has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2856)
2024 (3012)
2023 (3424)
2022 (4392)
2021 (3311)
2020 (5871)
Funding
Current Stage
Public CompanyTotal Funding
$4.72B2025-09-18Post Ipo Debt· $4.72B
1999-04-01IPO
Leadership Team
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