Principal Manufacturing Sciences & Technology Engineer (Biotech)

Location: East Greenbush, New York, United States. Onsite expectations with a Monday-Friday schedule from 8:00 a.m. to 4:30 p.m.; 25–50% domestic and occasional international travel.

Salary: $92,200–$150,600 annually.

Company

hirify.global is a biotechnology company that invents, develops, and commercializes medicines for serious diseases.

What you will do

• Lead drug product manufacturing process transfers, new product introductions, technology transfers, and process troubleshooting.
• Coordinate project milestones and cross-functional internal and external teams, including contract manufacturing organizations.
• Review and approve cGMP batch documentation, validation protocols, technical reports, policies, and change controls.
• Monitor manufacturing compliance, trend process performance, and support investigations into deviations and root causes.
• Develop and implement CAPA and sampling plans for lot release, stability, and characterization activities.
• Lead or support equipment selection, qualification, start-up, raw-material and component requirements, and operational procedure development.

Requirements

• BS or BA in Engineering, Chemical Engineering, or Biomedical Engineering preferred.
• 8+ years of relevant experience for the Principal MSAT Engineer level.
• Technical knowledge of drug product manufacturing, product development, validation, and interactions with contract manufacturing organizations.
• Strong knowledge of cGMP, Annex I, and applicable FDA, EMA, and MHRA practices and regulations.
• Ability to work onsite in East Greenbush, New York, United States and travel 25–50% domestically, with occasional international travel.

Nice to have

• Experience with equipment selection, qualification, process validation, cGMP start-up, and technology transfer.
• Experience leading cross-functional manufacturing and procurement initiatives.

Culture & Benefits

• Inclusive workplace with equal employment opportunity practices.
• Potential benefits include annual incentives, equity awards, retirement benefits, 401(k) matching, health and wellness programs, insurance, paid time off, and family support benefits.
• Reasonable accommodation is available during the recruitment process where required.