Industrial Automation Engineer (Pharma, GMP/GAMP 5)

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help innovative companies unleash their potential through R&D and engineering services.

We are looking for an Industrial Automation Engineer to lead and coordinate automation projects within a regulated pharmaceutical environment, ensuring compliance with GMP and GAMP 5 standards while delivering projects on time, within budget, and according to quality expectations.

Key Responsibilities

• Participate in defining user requirements (URS) and functional specifications (FS).
• Develop and monitor project timelines with Quality, Validation, Production, and Maintenance teams.
• Supervise external partners, including system integrators, electricians, and automation specialists.
• Track technical deliverables and ensure proper documentation.
• Validate PLC, SCADA, and DCS automation architectures in line with pharmaceutical standards.
• Organize and oversee FAT, SAT, IQ, and OQ qualification phases.
• Manage technical changes through the quality system and support audits.
• Draft and review electrical drawings, software programs, test protocols, and qualification reports.
• Ensure traceability and compliance with 21 CFR Part 11, data integrity, and cybersecurity requirements.
• Act as the main technical contact, lead project meetings, identify risks, and propose mitigation plans.

Required Skills

• Proven experience in automation within the pharmaceutical industry.
• Strong knowledge of GMP, GAMP 5, and validation processes.
• Familiarity with Siemens, Rockwell, or DeltaV platforms, including SIMATIC, PCS 7, and Opcenter Execution Pharma.
• Ability to manage multiple projects in a regulated environment.
• Excellent organization, attention to detail, analytical ability, and communication skills.
• Bachelor’s or Master’s degree in Automation, Industrial IT, Process Engineering, or an equivalent field.
• Significant pharmaceutical automation project-management experience.
• Upper-intermediate English.

Benefits

• Health insurance from the first days of employment.
• Christmas holidays from 25 December to 31 December.
• Support for Superhumans center and Veteran HUB initiatives.