Process Engineer IV (Biologics Manufacturing)

Location: Framingham, MA, United States; onsite manufacturing work

Salary: $100,500–$145,166.66 annually

Company

hirify.global is an R&D-driven, AI-powered biopharmaceutical company developing medicines and vaccines.

What you will do

• Provide technical and scientific leadership to biologics manufacturing and quality teams.
• Monitor manufacturing processes, assess process performance, and identify improvement opportunities.
• Lead root cause investigations, change assessments, debottlenecking, process validation, and continuous improvement.
• Lead technical and cross-functional project teams and coordinate support from process development groups.
• Support process scale-up, manufacturability, capacity analysis, cost analysis, and lifecycle improvements.
• Prepare regulatory documentation and provide CMC guidance for product lifecycle management.

Requirements

• Bachelor’s degree in engineering or science with 7 years of relevant GMP manufacturing experience, or a master’s degree with 5 years of relevant experience.
• Experience in pharmaceutical, biopharmaceutical, or other regulated manufacturing environments.
• Strong understanding of engineering principles, cGMP concepts, and quality and regulatory frameworks.
• Proficiency in process data analytics and familiarity with manufacturing systems such as DeltaV, Process Data Historian, LIMS, and MES.
• Experience leading projects or cross-functional teams, making independent decisions, and solving complex technical problems.
• Ability to gown and gain entry to manufacturing areas.

Nice to have

• Experience with biologics upstream or downstream unit operations, including perfusion or continuous operations.
• Experience communicating with business partners and senior management.

Culture & Benefits

• Work alongside a supportive, future-focused team in manufacturing and supply.
• Opportunities for professional growth through promotion or lateral career moves.
• Health and wellbeing benefits, including healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Employee rewards and benefits based on demonstrated contribution.