Validation Engineer – Injection Molding / Injectables / Automation

United Pharma; Illinois; On-site; USD 90,000 - 140,000; Full time

Job summary

United Pharma is seeking a highly experienced Validation Engineer to lead equipment qualification and process validation for injection molding and sterile manufacturing environments in Illinois. The role focuses on IQ/OQ/PQ execution, GMP compliance, and collaboration with Engineering, Quality, Manufacturing, and Automation teams.

The ideal candidate will have 5+ years in validation, hands-on experience with PLC/SCADA systems, and strong knowledge of FDA regulations and 21 CFR Part 11.

Qualifications

• 5+ years of validation engineering experience in regulated manufacturing.
• Hands-on validation with injection molding equipment and processes.
• Experience in injectable pharmaceuticals, biologics, sterile, or aseptic manufacturing.
• Strong knowledge of IQ/OQ/PQ, CSV, TMV, process validation, and GMP.
• Experience validating PLC-controlled equipment, HMI, SCADA, or automated manufacturing systems.
• Knowledge of FDA regulations, 21 CFR Part 11, deviations, CAPA, and change control.
• Experience with FAT/SAT, risk assessments, commissioning, and validation documentation.
• Bachelor’s degree in Engineering, Life Sciences, or related technical field.

Responsibilities

• Responsible for equipment qualification, injection molding and sterile manufacturing validation, automation system validation, protocol execution, deviation investigations, and GMP/FDA compliance.
• Collaborate with Engineering, Quality, Manufacturing, and Automation teams to support equipment commissioning, process improvements, and audit readiness.

Skills

Validation engineering

Regulated manufacturing

IQ/OQ/PQ

CSV

GMP

FDA regulations

Injection molding

PLC validation

Education

Bachelor’s degree in Engineering, Life Sciences or related field

Tools

DeltaV

Allen-Bradley

Siemens PLCs

SCADA

MES

Job description

5+ years of validation engineering experience in regulated manufacturing.

Hands-on injection molding equipment and process validation.

Experience in injectable pharmaceuticals, biologics, sterile, or aseptic manufacturing.

Strong knowledge of IQ/OQ/PQ, CSV, TMV, process validation, and GMP.

Experience validating PLC-controlled equipment, HMI, SCADA, or automated manufacturing systems.

Knowledge of FDA regulations, 21 CFR Part 11, deviations, CAPA, and change control.

Experience with FAT/SAT, risk assessments, commissioning, and validation documentation.

Bachelor’s degree in Engineering, Life Sciences, or a related technical field.

Preferred Skills:

Medical device manufacturing and molded plastic components.

DeltaV, Allen-Bradley, Siemens PLCs, SCADA, or MES.

Cleanroom/aseptic manufacturing, packaging validation, serialization, or automated inspection.

FDA audit and inspection support experience.

Role Overview:

Responsible for equipment qualification, injection molding and sterile manufacturing validation, automation system validation, protocol execution, deviation investigations, and GMP/FDA compliance. Collaborate with Engineering, Quality, Manufacturing, and Automation teams to support equipment commissioning, process improvements, and audit readiness.