Engineer - System Owner (Biotechnology)

Location: On site in New Albany, Ohio, United States

Salary: $88,281–$119,439 annual

Company

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

What you will do

• Own the technical aspects of manufacturing lines, packaging operations, manufacturing systems, pilot technologies, and capital projects.
• Resolve operational and technical problems and apply standard engineering techniques to system modifications, experiments, and projects.
• Audit operational performance and regulatory compliance of equipment and systems.
• Develop system modification requirements and recommendations with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation teams.
• Direct technical resources including mechanics, automation technicians, and IS teams, and define equipment requirements for service providers.
• Support design, engineering, and construction projects, including quotes, cost estimates, schedules, and standard design documents.

Requirements

• One of the following: a master’s degree; a bachelor’s degree plus 2 years of equipment experience in pharmaceutical, medical device, biotechnology, or related industries; an associate’s degree plus 6 years of such experience; or a high school diploma/GED plus 8 years of such experience.

Nice to have

• Advanced degree in mechatronics, computer, electrical, mechanical, or chemical engineering.
• Knowledge or experience with pharmaceutical and biotechnology processes, especially final drug product operations.
• Familiarity with packaging validation, serialization, networking, and documentation in highly regulated environments.
• Ability to operate specialized equipment, tools, and computers; interpret and apply GAMPs and GMPs; and apply engineering science to production.
• Knowledge of protocol requirements, validation protocol implementation, validation for new equipment installations, and technical writing.
• Organizational, project management, analytical problem-solving, communication, presentation, collaboration, influencing, and facilitation skills.
• Experience with protocol and script testing, change management, packaging equipment, operational excellence, and Lean transformation in automation and engineering.

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, stock-based long-term incentives, and a discretionary annual bonus program.
• Award-winning time-off plans and career development opportunities.
• Flexible work models may be available where possible, although this role is listed as on site.

Hiring process

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