Validation Engineer, Pharma Equipment & VHP/Aseptic

Sterling Engineering; Indianapolis (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Sterling Engineering is seeking a Validation Engineer for pharmaceutical manufacturing in Indianapolis, IN or remote in the Northeastern U.S. You will lead equipment qualification and VHP decontamination cycles while working with customers across North America.

The role involves developing IQ/OQ/PQ protocols, supporting commissioning and startup, and ensuring GMP-compliant documentation. Strong communication and travel are essential.

Qualifications

• Experience validating pharmaceutical equipment.
• Experience with VHP/VPHP decontamination cycles.
• Experience in aseptic processing or sterile pharmaceutical manufacturing.
• Ability to prepare IQ/OQ/PQ protocols and reports.
• Strong communication with customers.

Responsibilities

• Lead equipment validation activities, including FAT, SAT, IQ, OQ, and PQ.
• Develop and execute VHP decontamination cycles.
• Support commissioning, startup, and qualification of pharmaceutical manufacturing equipment.
• Work directly with customers at their manufacturing facilities throughout North America.
• Prepare validation protocols, reports, and GMP documentation.
• Ensure equipment and processes meet regulatory, quality, and customer requirements.
• Collaborate with engineering, quality, and project teams to deliver successful customer implementations.

Skills

Equipment validation

VHP/VPHP systems

Decontamination cycles

Aseptic processing

IQ/OQ/PQ documentation

Customer communication

Travel up to 60%

GMP documentation

Tools

Steris VHP generators

Job description

Sterling Engineering is seeking a Validation Engineer for pharmaceutical manufacturing in Indianapolis, IN or remote in the Northeastern U.S. You will lead equipment qualification and VHP decontamination cycles while working with customers across North America.

The role involves developing IQ/OQ/PQ protocols, supporting commissioning and startup, and ensuring GMP-compliant documentation. Strong communication and travel are essential.