Manufacturing Specialist-Process Engineer (Biotechnology)

Location: New Albany, Ohio, United States

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

Company

hirify.global is a biotechnology company developing, manufacturing, and delivering medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Execute manufacturing and quality systems covering continuous improvement, technology transfer, new product introductions, process validation, risk assessments, training, and non-conformance.
• Own, revise, and approve manufacturing procedures and assess process performance through floor observation and performance-data review.
• Develop and implement process improvements focused on cost and cycle-time reduction, including equipment and process modifications.
• Monitor critical process parameters and control limits, collect data, assess deviations, and prepare quarterly monitoring reports.
• Support non-conformance investigations, corrective actions, CAPA closure, root-cause analysis, and incident-trend evaluation.
• Participate in regulatory inspections, change-control assessments, and process-validation protocols and reports.

Requirements

• Doctorate degree, or a master's degree plus 2 years of relevant experience, or a bachelor's degree plus 4 years of relevant experience, or equivalent associate-degree or high-school experience pathways.
• Relevant experience must be in engineering, manufacturing, packaging, or quality within pharmaceutical, medical device, or biotechnology companies.
• Technical understanding of bioprocessing and manufacturing operations, including GMP production operations.
• Experience with process improvement, Lean principles, Kaizen, Six Sigma, operational excellence, and problem-solving techniques.
• Knowledge of change control, change management, regulatory interactions, data analysis, and control charting.
• Strong organizational, technical writing, presentation, verbal communication, and project management skills.

Culture & Benefits

• Collaborative, innovative, and science-based work environment focused on serving patients.
• Health, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
• 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.

Hiring process

• Sponsorship for this role is not guaranteed.
• Reasonable accommodation is available for candidates with disabilities during the application and interview process.