Area Lead Automation Engineer

Leap29; Indianapolis (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Leap29 seeks an Automation Area Lead for a major pharma manufacturing program in Indiana. The role provides technical ownership of automation systems within a defined project area and operates in a hybrid setup with on-site requirements during design and commissioning.

The candidate will ensure alignment with automation philosophy, standards, and user requirements, collaborating closely with technical leads and system integrators. A strong GMP/CSV background is essential.

Qualifications

• Bachelor’s degree in Engineering or equivalent experience.
• 8+ years of automation experience in the pharmaceutical industry (API or bulk manufacturing).
• 5+ years hands-on DeltaV Batch DCS experience.
• Proven track record delivering large-scale pharma automation projects.
• Experience with Allen-Bradley PLCs is a plus.
• Strong teamwork and communication skills across technical and non-technical teams.
• Deep understanding of GMP, regulatory compliance, and CSV principles.

Responsibilities

• Act as the technical owner for automation scope of a defined project area.
• Define the S88 software structure and component list for the area.
• Develop Functional Design Specifications (FDS) with system integrators.
• Review P&ID and control strategies to align with project goals.
• Ensure automation solutions meet standards, schedules, and budgets.
• Collaborate with the Project Technical Lead, Automation Project Manager, and System Integrator.
• Maintain consistency and compliance across all automation deliverables (requirements, FDS, control strategies, recipes).
• Support software definition, testing, issue tracking, and remediation activities.
• Contribute to risk analysis and mitigation planning for technical challenges.
• Ensure work complies with GMP and regulatory standards.

Skills

Teamwork

Communication

Project management

GMP/CSV knowledge

Education

Bachelor's degree in Engineering

Tools

DeltaV Batch DCS

Allen-Bradley PLCs

Job description

Automation Area Lead Location: Indiana, USA (Hybrid) Duration: 12 month renewable contract

Overview

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.

Key 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.

Qualifications

• 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.
• Experience with Allen‑Bradley PLCs is a plus.
• 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.