Process Characterization & Technology Engineer

Location: East Greenbush, New York, United States. Onsite Monday–Friday, 8:00 a.m.–4:30 p.m.

Company

hirify.global is a biotechnology company that develops and commercializes medicines for serious diseases, including combination products such as drug-delivery devices.

What you will do

• Guide process development and scale-up for GMP assembly of prefilled syringes, autoinjectors, and on-body injectors.
• Translate quality targets into critical quality attributes, process parameters, risk-based characterization plans, and control strategies using ICH, QbD, and FMEA principles.
• Plan and execute process characterization studies using design of experiments, statistical analysis, engineering studies, and tools such as JMP and Minitab.
• Develop in-process controls, sampling plans, PPQ approaches, and statistical process control and capability monitoring with internal and external partners.
• Support equipment and tooling qualification, including URS/FRS, FAT/SAT, IQ/OQ/PQ, and continued process verification.
• Coordinate with QA, RA, Device Engineering, CMC, Supply Chain, and external CMOs to support technology transfer, operational readiness, and regulatory filings.

Requirements

• Bachelor’s degree in Engineering, Mechanical, Biomedical, Chemical, or Manufacturing Engineering preferred.
• Level is determined by experience: Associate Process Controls & Validation Engineer requires 0–2 years; Process Controls & Validation Engineer requires 2 or more years.
• Experience with process characterization, design of experiments, statistical analysis, process validation, and control strategies.
• Knowledge of 21 CFR Parts 4, 210/211, and 820; ISO 13485; and ISO 14971 risk management.
• Ability to maintain compliant documentation, change controls, deviation investigations, CAPAs, SOPs, work instructions, and electronic records.

Nice to have

• Experience with autoinjectors, pen injectors, or prefilled syringes.
• Experience working with CMOs/CDMOs and executing technology transfers across sites.
• Experience with packaging and labeling lines, print and vision inspection, barcode and 2D codes, serialization/UDI, tamper evidence, and transport or distribution simulation.

Culture & Benefits

• Work with cross-functional internal and external partners across process sciences, quality, regulatory, engineering, supply chain, and manufacturing.
• Benefits may include incentive plans, equity awards, retirement benefits, health and wellness programs, insurance, paid time off, and family support benefits.
• Inclusive workplace with reasonable accommodation available during recruitment where required.