Pharma Automation Engineer – Capital Projects Leader

BioTalent; Indianapolis (IN); On-site; USD 95,000 - 140,000; Full time

Job summary

BioTalent in Indianapolis seeks an experienced Automation Engineer to lead automation and controls for a major pharmaceutical capital project, guiding design, build, commissioning, qualification, and startup activities for new manufacturing lines and processes.

The role centers on FAT, SAT, C&Q, IQ/OQ, and data integrity, with collaboration across EPCs, vendors, and internal teams to meet GMP and regulatory requirements.

Qualifications

• Bachelor's degree in a relevant engineering field.
• 5+ years of automation experience in regulated manufacturing.
• Experience supporting capital projects, startups, or line installations.
• Hands-on FAT and SAT execution experience.
• Strong knowledge of PLC, DCS, SCADA, HMI and industrial control systems.
• Experience with GMP, 21 CFR Part 11, Annex 11.
• Ability to collaborate with EPCs, vendors and cross-functional teams.

Responsibilities

• Lead FAT activities for equipment, packaging, utilities, and integrated platforms.
• Coordinate SATs after installation and drive deviations closure.
• Support C&Q activities including IQ/OQ testing and validation.
• Partner with Validation and Quality to ensure data integrity and compliance.
• Provide automation support during startup and operational readiness.

Skills

Electrical Engineering

Automation Engineering

Chemical Engineering

Computer Engineering

GMP Knowledge

PLC

DCS

SCADA

HMI

FAT/SAT

Validation

OSI PI

Education

Bachelor's degree in Electrical Engineering / Automation Engineering / Chemical Engineering / Computer Engineering

Tools

DeltaV

Rockwell Automation

Siemens

PCS7

OSI PI

Historian systems

MES interfaces

Electronic Batch Records

Job description

BioTalent in Indianapolis seeks an experienced Automation Engineer to lead automation and controls for a major pharmaceutical capital project, guiding design, build, commissioning, qualification, and startup activities for new manufacturing lines and processes.

The role centers on FAT, SAT, C&Q, IQ/OQ, and data integrity, with collaboration across EPCs, vendors, and internal teams to meet GMP and regulatory requirements.