Specialist - Manufacturing - Engineering Support (Biotech)

Location: US - Ohio - New Albany

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

Company

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

What you will do

• Develop, review, and update SOPs, work instructions, protocols, risk assessments, technical reports, and training materials in a GMP-regulated manufacturing environment.
• Own and provide subject matter expertise for deviations, CAPAs, change controls, and quality risk management records.
• Support manufacturing documentation, data collection, technical document tracking, and timely completion of related actions.
• Develop protocols for change control, deviation, and troubleshooting investigations with relevant subject matter experts.
• Collaborate with Manufacturing, Quality Assurance, and cross-functional departments on documentation and training changes.
• Support continuous process improvement, troubleshooting projects, and efforts to reduce document turnaround times.

Requirements

• Doctorate degree; or a master’s degree plus 2 years, bachelor’s degree plus 4 years, associate’s degree plus 8 years, or high school diploma/GED plus 10 years of relevant experience.
• Experience in Engineering, Manufacturing, Packaging, or Quality within pharmaceutical, medical device, or biotechnology companies.
• Experience in GMP manufacturing and technical writing.
• Strong documentation, communication, prioritization, troubleshooting, and problem-solving skills.
• Ability to translate technical information into clear materials for manufacturing operators.
• Experience supporting deviations, investigations, CAPAs, and change controls is preferred.

Culture & Benefits

• Collaborative, innovative, science-based work environment.
• Health, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual bonus program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Flexible work models where applicable to the role.

Hiring process

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