Process Engineer (Biopharma Manufacturing)

Location: Boulder, Colorado, United States; onsite at a GMP manufacturing facility

Salary: $103,200–$161,250 per year, plus eligibility for bonus, stock, and benefits.

Company

hirify.global provides life science, diagnostic, and applied market laboratories with instruments, services, consumables, applications, and expertise.

What you will do

• Provide process engineering support for GMP manufacturing across upstream, midstream, downstream, and utility operations.
• Own designated manufacturing process areas, including process monitoring, troubleshooting, optimization, and lifecycle management.
• Support technical transfers, process scale-up, continuous improvement, root cause investigations, and corrective actions.
• Coordinate multidisciplinary teams and collaborate with manufacturing, quality assurance, chemical development, validation, safety, and project management groups.
• Support capital projects from user requirements and process design through equipment procurement, installation, commissioning, qualification, and handover.
• Support validation and regulatory activities, including FAT/SAT, IQ/OQ/PQ, change controls, CAPAs, audit responses, and CGMP compliance.

Requirements

• Bachelor’s or master’s degree in chemical, mechanical, or electrical engineering, or equivalent education and experience.
• 4+ years of combined experience in the pharmaceutical, biopharmaceutical, or fine chemicals industry.
• 3+ years of experience with process and instrumentation diagrams, facility layouts, equipment sizing calculations, URSs, SOPs, and process troubleshooting.
• Ability to work independently and solve complex manufacturing and process engineering problems through structured analysis.
• Experience using engineering and manufacturing data to identify trends, investigate deviations, perform root cause analysis, and drive process improvements.
• Ability to work onsite at the Boulder, Colorado GMP facility.

Nice to have

• Experience supporting projects through architectural and engineering design, process safety management, hazard analysis, procurement, installation, commissioning, and qualification.
• Knowledge of ASME BPE sanitary piping and equipment design standards, NFPA 70/NEC, and international fire and building codes.
• Biopharmaceutical project management experience.
• Experience with SCADA, PLC, BAS, industrial control system design and programming, and validation documentation.

Culture & Benefits

• Full-time day-shift position with no defined end date.
• Approximately 10% travel required.
• Eligibility for bonus, stock, and benefits.
• Inclusive, equal-opportunity workplace committed to accessibility and supporting individuals from diverse backgrounds.