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

Commissioning & Qualification Engineer Jr.

At Ultimate Solutions we deliver engineering automation serialization and compliance solutions to the worlds 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.

What Youll Do

• 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.

What Were Looking For

• Bachelors 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.

Preferred Qualifications

• 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.

Why Join Ultimate Solutions

• Work on cutting-edge biotech manufacturing projects.
• Join a collaborative and highly technical engineering team.
• Career growth opportunities within a global engineering organization.
• Exposure to large-scale GMP startup and expansion projects.
• Competitive compensation and professional development opportunities.

Not open for Corp-to-Corp arrangements

Equal Opportunity Employer

Ultimate Solutions is an Equal Opportunity Employer. We are committed to creating an inclusive workplace where all employees and applicants are treated with respect and provided equal employment opportunities regardless of race color religion sex national origin disability veteran status or any other protected characteristic under applicable law.