Associate Mfg Systems Engineer I (Biotech)

Location: US - North Carolina - Holly Springs

Salary: $86,685.55–$117,280.45 USD annually

Company

hirify.global is a biotechnology company that researches, manufactures, and delivers medicines for serious illnesses across oncology, inflammation, general medicine, and rare disease.

What you will do

• Lead the development and implementation of validation strategies for the North Carolina manufacturing facility.
• Develop the Validation Master Plan, validation plans, equipment qualification protocols, and reports.
• Support commissioning, qualification, cleaning and sterilization validation, and validation maintenance activities.
• Coordinate autoclave performance qualification, cleaning validation, and other validation milestones.
• Collaborate with Manufacturing, Engineering, Quality, Supply Chain, and Process Development.
• Support site and network validation-driven continuous improvement initiatives.

Requirements

• High school diploma or GED with 6 years of Manufacturing or Operations experience, an associate’s degree with 4 years of experience, or a bachelor’s degree.
• Experience or ability to develop expertise in equipment qualification, cleaning validation, sterilization validation, and biologics manufacturing validation strategies.
• Ability to review and approve validation protocols and reports for facility and equipment commissioning, qualification, and change administration.
• Technical writing and presentation skills for collaboration with technical and senior management staff.
• Ability to read P&IDs and manage multiple projects.

Nice to have

• Experience with Kneat, CDOCs, Laboratory Inventory Management System, and Pi.
• Sample Management lifecycle experience.
• Experience with steaming validation, autoclaves, and controlled temperature chambers.

Culture & Benefits

• Comprehensive medical, dental, vision, life, disability, and flexible spending benefits.
• Retirement and savings plan with company contributions.
• Discretionary 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.