Industrial Automation Engineer (Pharma, GMP/GAMP 5)

Role summary:

We're looking for a specialist to lead and coordinate automation projects within a regulated pharmaceutical environment, ensuring compliance with GMP and GAMP 5 standards, while delivering on time, within budget, and according to quality expectations. The engineer will act as a technical and operational interface between internal teams, suppliers, and subcontractors. 

Key Responsibilities:

1. Project Management :
• Participate in the definition of user requirements (URS) and functional specifications (FS).
• Develop and monitor project timelines in coordination with Quality, Validation, Production, and Maintenance teams.
• Supervise external partners (system integrators, electricians, automation specialists).
• Track technical deliverables and ensure proper documentation.
2. Technical & Regulatory Oversight:
• Validate automation architectures (PLC, SCADA, DCS..) in line with pharmaceutical standards.
• Organize and oversee qualification phases: FAT, SAT, IQ, OQ.
• Manage technical changes within the quality system (Change Control).
• Support internal and external audits (quality and regulatory).
3. Documentation & Validation:
• Draft and review project documentation: electrical drawings, software programs, test protocols, qualification reports.
• Ensure traceability and compliance with regulatory requirements (e.g., 21 CFR Part 11, Data Integrity, cyber security).
• Collaborate with validation teams to ensure system compliance.
4. Communication & Coordination:
• Act as the main technical point of contact for stakeholders.
• Lead project meetings and technical reviews.
• Identify project 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 industrial automation platforms (e.g., Siemens (SIMATIC, PCS 7, Opcenter Execution Pharma) Rockwell, DeltaV).
• Ability to manage multiple projects in a regulated environment.
• Excellent organizational skills, attention to detail, analytical mindset, and interpersonal communication.
• Bachelor’s or Master’s degree in Automation, Industrial IT, Process Engineering, or equivalent.
• Significant experience in automation project management in the pharmaceutical sector.
• English - Upper-intermediate

What you will love about working here?

• We care about all our employees and want them to feel as comfortable as possible. That's why we offer them health insurance from the first days, regardless of the probationary period.
• The gift from the company - Christmas holidays from 25 December to 31 December.
• Сooperation with Superhumans center and Veteran HUB. Capgemini Engineering has supported the launch of psychological rehabilitation department of Superhumans. Our team also donnated over UAH 500 000 prosthetics for three Ukrainian defenders. Currently, we support psychological counseling provided by the Veteran Hub, and we have implemented a internal policy making the company friendly to military and veterans with the assistance of the Hub.