Process Engineer - Advanced (Biopharma)

Location: Frederick, Colorado, United States; onsite work at a GMP API-biopharma 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 laboratory instruments, services, consumables, applications, and expertise worldwide.

What you will do

• Troubleshoot manufacturing operations, support maintenance activities, and identify process improvement and optimization opportunities.
• Lead capital projects from user requirements and process design through equipment procurement, installation, commissioning, qualification, and handover to manufacturing.
• Manage project schedules, budgets, and multidisciplinary team coordination.
• Support technical transfer and process scale-up into manufacturing for Chemical Development and Manufacturing Services.
• Support EHS, process hazard analysis, pre-startup safety reviews, process safety management, and validation activities.
• Prepare, review, and resolve quality documentation including change controls, CAPAs, audit responses, and qualification reports.

Requirements

• Bachelor’s or master’s degree in Chemical Engineering or equivalent education and experience.
• 4+ years of combined experience in pharmaceutical, biopharmaceutical, or fine chemicals industries.
• 3+ years of experience with P&IDs, facility layouts, mass and energy balances, solvent handling, equipment sizing, URSs, SOPs, and process troubleshooting.
• Experience managing projects through design, process hazard analysis, procurement, installation, commissioning, and qualification phases.
• Ability to work independently with limited direction in a fast-paced manufacturing environment.

Nice to have

• Knowledge of ASME BPE, NFPA 70/NEC, and international fire and building codes.
• Experience with SCADA, PLCs, BAS, and IQ/OQ/PQ validation documentation.
• Ability to use AutoCAD or Visio.

Culture & Benefits

• Full-time day-shift schedule with occasional travel.
• Opportunity to contribute to oligonucleotide DNA-RNA therapeutics manufacturing.
• Eligibility for bonus, stock, and employee benefits.
• Inclusive, equal-opportunity workplace supporting accessibility and employees from diverse backgrounds.