Senior Engineer, Manufacturing Sciences (Biologics)

Location: USA - NC - Durham - National Way

Company

hirify.global provides biopharmaceutical manufacturing and manufacturing sciences services for client programs.

What you will do

• Provide technical expertise and process ownership for cGMP downstream biologics production runs.
• Transfer processes from development into manufacturing, including process descriptions and site implementation requirements.
• Develop and implement process validation, monitoring strategies, and compliance documentation.
• Serve as the primary client contact for process requirements, transfer plans, modifications, and performance criteria.
• Lead cross-functional teams across Manufacturing, Validation, QA, Facilities & Engineering, Supply Chain, IT, Automation, QC, and Process Development.
• Troubleshoot complex technical issues and drive process improvements and optimization.

Requirements

• Bachelor’s degree in science or engineering with at least 9 years of industry experience, or a master’s degree with at least 7 years, or a PhD with at least 5 years.
• Professional expertise in biologics, upstream or downstream processing, technical transfer, and operational support.
• Strong experience in cGMP manufacturing operations and technical transfer.
• Experience with scale-up processes; familiarity with process validation and GMP compliance requirements.
• Experience leading projects and cross-functional initiatives with a detail-oriented, quality-focused approach.

Culture & Benefits

• Collaborative environment involving manufacturing, quality, engineering, automation, supply chain, IT, QC, and process development functions.
• Direct engagement with clients and opportunities to influence production success and client satisfaction.
• Exposure to advanced technologies in manufacturing science and technology.
• Professional growth opportunities in a dynamic biopharmaceutical manufacturing environment.