Manufacturing Specialist-Process Engineer (Biotechnology)

Location: New Albany, Ohio, United States; onsite manufacturing role

Salary: USD 107,545.40–145,502.60 per year

Company

hirify.global develops, manufactures, and delivers biotechnology medicines across oncology, inflammation, general medicine, and rare disease.

What you will do

• Own, revise, and approve manufacturing procedures and assess process performance through floor observation and performance-data review.
• Identify and implement process improvements, including cost and cycle-time reduction initiatives, and support training and risk evaluations.
• Support process monitoring, control limits, quarterly reports, deviation assessment, technology transfer, and new product introductions.
• Assess and support process or equipment modification projects, including documentation, materials, training, and implementation.
• Support non-conformance investigations, corrective actions, CAPA closure, root-cause analysis, trend evaluation, and change control.
• Support process validation protocols, reports, data analysis, and participation in regulatory inspections.

Requirements

• Doctorate degree; or a master’s degree plus 2 years of engineering, manufacturing, packaging, or quality experience; or a bachelor’s degree plus 4 years of such experience; or an associate’s degree plus 8 years; or a high school diploma/GED plus 10 years.
• Required experience must be in pharmaceutical, medical device, or biotechnology companies.

Nice to have

• Detailed technical understanding of bioprocessing and manufacturing operations.
• Experience developing, managing, and implementing process improvements.
• Experience with Lean principles, including Kaizen, Six Sigma, and Operational Excellence, and with problem-solving techniques.
• Experience participating in or helping lead cross-functional teams and collaborating with manufacturing, process development, quality, technical, and management staff.
• Experience with change control and change management, GMP production operations, regulatory knowledge and interactions, and project management.
• Excellent organizational, technical writing, presentation, and verbal communication skills.
• Knowledge of data analysis and control charting.

Culture & Benefits

• Collaborative, innovative, and science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions and stock-based long-term incentives.
• Discretionary annual bonus program and award-winning time-off plans.
• Career development opportunities and flexible work models where applicable.