KBI: US - Process Engineer III (Biopharma)

Location: USA - NC - Durham - National Way

Company

hirify.global provides biopharmaceutical development and manufacturing capabilities for biologics and advanced therapies.

What you will do

• Support the implementation, commissioning, qualification, startup, and validation of manufacturing process equipment and facility systems.
• Lead the development, scale-up, optimization, and troubleshooting of upstream and downstream bioprocesses, including cell culture, fermentation, harvest, chromatography, purification, and filtration.
• Design and execute experiments to improve process robustness, yield, scalability, and product quality.
• Lead engineering projects involving equipment upgrades, facility fit, capital projects, new technologies, and continuous improvement.
• Collaborate with Engineering, MS&T, Manufacturing, Quality, Regulatory, and other KBI sites on technology transfer, GMP compliance, and process consistency.
• Support deviations, CAPAs, change controls, risk assessments, root cause investigations, audits, and regulatory filings.

Requirements

• Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or a related field.
• 5+ years of experience in bioprocess development or manufacturing within the biotech or biopharma industry.
• Experience with biologics, cell therapy, gene therapy, or drug substance production processes.
• Strong understanding of cGMP regulations, FDA/EMA guidelines, and validation principles.
• Proficiency in process modeling and simulation tools, along with strong analytical and problem-solving skills.
• Demonstrated leadership in cross-functional teams, project management, technical documentation, and concurrent project coordination.

Nice to have

• Experience with regulatory submissions such as IND, BLA, or MAA.
• Experience with single-use systems, PAT tools, or continuous processing.

Culture & Benefits

• Work in a cross-functional environment supporting commercial cGMP production.
• Contribute to continuous improvement across processes, tools, and KBI sites.
• Participate in evaluating technologies that improve manufacturing scalability and efficiency.
• hirify.global is an EEO/AA employer committed to workforce diversity.