Biopharma Automation Project Lead

R&D Partners; Chicago (IL); On-site; USD 140,000 - 200,000; Full time

Job summary

R&D Partners is seeking an Automation Project Manager to lead planning, execution, and delivery of automation systems for large-scale biopharmaceutical capital projects within a regulated manufacturing environment. You will ensure regulatory compliance, seamless integration with Operations, and a smooth handover while managing scope, budget, schedules, and vendor performance.

The role requires collaboration with engineering, manufacturing, quality, validation, and IT-OT teams to deliver

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 8–15 years delivering automation solutions in biopharmaceutical manufacturing or regulated industries.
• Demonstrated experience leading automation execution on large capital projects.
• Strong GMP automation, CSV, ALCOA data integrity, and regulatory inspection knowledge.
• Proven experience managing multidisciplinary teams, contractors, and automation vendors.

Responsibilities

• Coordinate integration of automation systems across DCS, PLCs, MES, EBR, data historians, and site infrastructure.
• Collaborate with engineering, manufacturing, quality, validation, IT-OT, and system owners to deliver integrated solutions.
• Ensure compliance with cGMP, ALCOA, cybersecurity, and company automation standards throughout the project lifecycle.
• Lead automation activities from design through commissioning, qualification, validation, and handover to operations.
• Manage project scope, schedules, budgets, forecasts, and vendor commitments to ensure successful delivery.
• Identify, assess, and mitigate project risks; provide timely resolution of issues.
• Drive handover to Operations with complete documentation, training, and readiness criteria.
• Provide executive-level communication on status, risks, decisions, and trade-offs.
• Support regulatory inspections, audits, and validation activities for automation systems.
• Ensure automation systems comply with industry standards, validation requirements, and governance.

Skills

Automation Project Management

Cross-functional Leadership

Strategic Planning

Budget and Forecast Management

Vendor Management

Risk and Issue Management

Executive Communication

Operational Readiness

Problem Solving & Decision Making

Education

Bachelor's degree in Engineering or related technical discipline

Tools

DCS

PLCs

MES

SCADA

HMI

EBR

Data Historians

ISA-88/ISA-95

Job description

R&D Partners is seeking an Automation Project Manager to lead planning, execution, and delivery of automation systems for large-scale biopharmaceutical capital projects within a regulated manufacturing environment. You will ensure regulatory compliance, seamless integration with Operations, and a smooth handover while managing scope, budget, schedules, and vendor performance.

The role requires collaboration with engineering, manufacturing, quality, validation, and IT-OT teams to deliver