Specialist - Manufacturing - Engineering Support (Biotechnology)

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

Company

hirify.global is a biotechnology company that researches, manufactures, and delivers medicines for serious illnesses.

What you will do

• Develop, review, and update SOPs, work instructions, protocols, risk assessments, technical reports, and training materials for manufacturing.
• Own and provide subject matter expertise for deviations, CAPAs, change controls, and other Quality System records.
• Prepare documentation, compile data, track technical activities, and reduce document turnaround times.
• Develop protocols for change controls, deviation investigations, troubleshooting, and manufacturing execution.
• Collaborate with Manufacturing, Quality Assurance, process owners, and other cross-functional departments.
• Support continuous process improvement, operator training, and GMP compliance.

Requirements

• Doctorate degree, or a relevant master's degree with 2 years of experience, bachelor's degree with 4 years, associate's degree with 8 years, or high school diploma/GED with 10 years of experience.
• Experience in engineering, manufacturing, packaging, or quality within pharmaceutical, medical device, or biotechnology companies.
• Experience in a GMP-regulated environment and strong technical writing skills.
• Experience supporting deviations, investigations, CAPAs, and change controls.
• Ability to translate technical information into clear instructions for manufacturing operators.
• Strong troubleshooting, problem-solving, documentation, communication, prioritization, and deadline-management skills.

Nice to have

• Experience with device assembly and final-product packaging.
• Ability to create effective photographs, drawings, diagrams, animations, and charts for training and documentation.

Culture & Benefits

• Comprehensive medical, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Annual discretionary bonus program and stock-based long-term incentives.
• Flexible work models where applicable to the assigned work location.
• Paid time off and career development opportunities.