Leap29

Compensation

Full Description

About the position A global leader in Life Science Manufacturing Technology Solutions is seeking a highly skilled and experienced Automation Area Lead to join their team. This role will support a major pharmaceutical manufacturing program, providing technical ownership of automation systems for a defined project area. The successful candidate will ensure alignment with overall program standards, automation philosophy, and user requirements. This is a hybrid role requiring a minimum of one week per month on-site in Indiana during the design phases, with full-time on-site presence required during commissioning. Responsibilities • Act as the technical owner for the automation scope of a specific project area. • Define the S88 software structure and component list for the assigned area. • Develop and refine Functional Design Specifications (FDS) in collaboration with system integrators. • Participate in P&ID and control strategy reviews to ensure alignment with project goals. • Ensure automation solutions meet project standards, schedules, and budgets. • Collaborate closely with the Project Technical Lead, Automation Project Manager, and System Integrator. • Maintain consistency and compliance across all automation deliverables, including requirements, FDS, control strategies, and recipes. • Support software definition, testing, issue tracking, and remediation activities. • Contribute to risk analysis and mitigation planning for technical challenges. • Ensure all work complies with GMP and relevant regulatory standards. Requirements • Bachelor’s degree in Engineering or equivalent experience. • A minimum of 8 years of automation experience in the pharmaceutical industry, ideally in API or bulk manufacturing. • At least 5 years of hands-on experience with DeltaV Batch DCS. • Proven track record of delivering large-scale pharmaceutical automation projects. • Strong teamwork and communication skills, with the ability to collaborate effectively across technical and non-technical teams. • In-depth understanding of GMP, regulatory compliance, and computer system validation (CSV) principles. Nice-to-haves • Experience with Allen-Bradley PLCs is a plus.