Validation Engineer I (Biopharmaceutical Manufacturing)

Location: Holly Springs, North Carolina, United States

Salary: $85,878.05–$116,187.95 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

• Develop and implement the validation strategy for a biopharmaceutical manufacturing facility.
• Create and maintain validation master plans, validation plans, equipment qualification protocols, reports, and related documentation.
• Lead or support commissioning, qualification, cleaning validation, sterilization validation, and validation maintenance activities.
• Conduct performance qualifications for parts washers and autoclaves and support periodic cleaning monitoring.
• Collaborate with Manufacturing, Engineering, Quality, Supply Chain, Process Development, and other technical functions.
• Provide troubleshooting, root cause analysis, corrective and preventive action support, regulatory inspection assistance, and rotational 24/7 on-call support.

Requirements

• High school diploma/GED with 8 years of Manufacturing or Operations experience, an Associate’s degree with 6 years of experience, a Bachelor’s degree with 2 years of experience, or a Master’s degree.
• Experience with equipment qualification and cleaning validation in a biologics facility is preferred.
• Knowledge of GMP requirements and regulations including EU GMP Annex 15, FDA 21 CFR Parts 210 and 211, ASTM E2500, and ICH Q7 is preferred.
• Technical writing, presentation, analytical, project management, and cross-functional collaboration skills are required.
• Experience reviewing validation protocols and reports, supporting regulatory submissions and inspections, and managing multiple priorities is preferred.
• Experience with Kneat, CDOCs, Laboratory Inventory Management System, Pi, mammalian cell culture, protein purification, clean utilities, CIP, SIP, or biopharmaceutical manufacturing equipment is preferred.

Culture & Benefits

• Collaborative, innovative, and science-based working 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.