Validation Engineer (Biotechnology)

Location: West Greenwich, Rhode Island, United States; onsite Monday–Friday administrative day shift

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

• Support validation strategy and execute validation activities for manufacturing equipment, support equipment, utilities, and facility systems.
• Plan, coordinate, and execute qualification activities for CIP, SIP, autoclave, airflow visualization, benchtop equipment, and supporting utility systems.
• Develop validation plans, protocols, reports, impact assessments, and lifecycle documentation.
• Serve as the validation technical expert during project planning, design reviews, equipment implementation, and change control.
• Execute cleaning validation and continued cleaning verification, including calculating maximum allowable carryover and maintaining cleaning acceptance criteria.
• Investigate technical issues, provide solutions, improve validation procedures, and train manufacturing staff.

Requirements

• High school diploma/GED and 8 years of manufacturing and operations experience, or an associate degree and 6 years, or a bachelor’s degree and 2 years, or a master’s degree.
• Experience in GMP pharmaceutical or biotechnology manufacturing, preferably with upstream or downstream operations.
• Hands-on experience with equipment qualification, sterilization/steaming, cleaning validation, and performance studies.
• Strong understanding of GMP requirements, applicable CFR and regulatory expectations, pharmaceutical or biotechnology unit operations, and manufacturing equipment.
• Ability to interpret engineering and automation documentation, evaluate validation data, resolve technical issues, and prepare compliant documentation.
• Ability to work onsite in West Greenwich, Rhode Island, Monday through Friday on the administrative day shift.

Culture & Benefits

• Collaborative, innovative, science-based work environment focused on serving patients.
• Comprehensive health, 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.
• Visa sponsorship is not guaranteed for this role.