Commissioning & Qualification Engineer, Jr. – New Albany, Ohio

Ultimate Solutions•New Albany, OH

35d•Onsite

About The Position

At Ultimate Solutions, we deliver engineering, automation, serialization, and compliance solutions to the world’s leading pharmaceutical, biotechnology, medical device, and logistics companies. For more than 20 years, our team has successfully supported complex manufacturing and packaging projects across Puerto Rico, the United States, and Europe. We are known for delivering high-impact technical solutions, strong client partnerships, and exceptional project execution in highly regulated industries. We are currently seeking a motivated and hands-on Commissioning & Qualification (C&Q) Engineer, Jr. to support exciting biotech manufacturing startup and expansion projects in New Albany. This is an excellent opportunity for engineers with solid GMP experience who want to grow their careers while working alongside experienced industry leaders in a fast-paced and highly technical environment.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
Minimum of 2 years of solid experience in Commissioning, Qualification, Validation, or related GMP-regulated activities.
Experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
Working knowledge of IQ/OQ/PQ methodologies, GMP regulations, and industry standards.
Ability to read and interpret P&IDs, engineering drawings, and technical documentation.
Strong technical writing, organizational, and problem-solving skills.
Team-oriented mindset with excellent communication skills.
Ability and willingness to travel to OEM/vendor facilities for FAT execution and project support.
Willingness to work in a dynamic, schedule-driven project environment.

Nice To Haves

Experience supporting biotech or pharmaceutical startup projects.
Familiarity with ISPE Baseline Guides and ASTM E2500.
Exposure to automation systems, utilities, or process equipment qualification.
Knowledge of risk-based C&Q methodologies.
Experience supporting deviations, investigations, and change control processes.

Responsibilities

Support commissioning and qualification activities for process equipment, utilities, facilities, packaging systems, and automation platforms.
Execute and document IQ, OQ, and PQ protocols in compliance with GMP and regulatory requirements.
Assist with startup, troubleshooting, testing, and system turnover activities.
Develop and review C&Q documentation including protocols, reports, test scripts, and traceability matrices.
Verify systems meet design specifications, user requirements, and operational expectations.
Collaborate with engineering, automation, validation, manufacturing, and quality teams to meet project milestones.
Support deviation investigations, change controls, and CAPA activities.
Maintain accurate, audit-ready documentation throughout project execution.
Travel to OEM/vendor facilities to support and execute Factory Acceptance Testing (FAT) and validation activities prior to equipment shipment and site installation.
Promote safe work practices and compliance with environmental and quality standards.