Senior Engineer, MS&T (Biopharma)

Location: Boulder, Colorado, United States. On-call and manufacturing-floor support for 24/7 plant operations is required on a rotating basis.

Salary: $118,000–$178,000 annually, plus an annual bonus structure.

Company

hirify.global provides biopharmaceutical development and manufacturing services.

What you will do

• Own process engineering decisions for product technology transfer and implementation, mainly for downstream processes.
• Serve as a subject matter expert for downstream drug substance operations, including chromatography, tangential flow filtration, clarification, and normal filtration.
• Author, review, and approve process descriptions, process qualification protocols and reports, and continued process verification reports.
• Develop technical solutions for complex manufacturing and engineering problems using internal and external expertise.
• Plan and conduct engineering studies, delegate work, and manage project resources.
• Collaborate with Facilities and Engineering, Process Development, Supply Chain, Quality, Manufacturing, and clients to execute projects efficiently.

Requirements

• Bachelor’s degree in chemical engineering, biochemical engineering, or a related field.
• 11+ years of experience in bioprocess development or manufacturing within the biotech or biopharma industry.
• Expertise in biologics, cell therapy, gene therapy, and drug substance production processes.
• Strong knowledge of cGMP regulations, FDA and EMA guidelines, process validation, and regulatory expectations.
• Demonstrated leadership in cross-functional teams, project management, communication, analysis, and problem-solving.
• Availability for rotating on-call and manufacturing-floor support for 24/7 plant operations.

Nice to have

• Experience with IND, BLA, or MAA regulatory submissions.

Culture & Benefits

• Full-time employment with medical, dental, and vision coverage.
• Paid time off and holidays.
• 401(k) matching with 100% vesting after 60 days.
• Annual bonus structure and employee recognition programs.
• Cross-functional collaboration with technical, quality, manufacturing, and client-facing teams.