Validation Engineer (Biotechnology)

Location: US - Rhode Island - West Greenwich. Full-time, Monday–Friday administrative day shift.

Annual salary: USD 85,878.05–116,187.95.

Company

hirify.global is a biotechnology company researching, manufacturing, and delivering medicines 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, performance qualifications, equipment releases, lifecycle documentation, and validation impact assessments.
• Act as a validation technical expert during project planning, design reviews, equipment implementation, and change control.
• Support cleaning validation and continued cleaning verification, including MAC calculations and scientific justification of acceptance criteria.
• Investigate technical issues, resolve validation challenges, improve validation programs, and provide training to manufacturing staff.

Requirements

• High school diploma/GED plus 8 years of Manufacturing and Operations experience, or an associate’s degree plus 6 years, or a bachelor’s degree plus 2 years, or a master’s degree.
• Experience in a GMP pharmaceutical or biotechnology manufacturing environment, preferably with upstream or downstream operations.
• Hands-on experience with equipment qualification, sterilization or steaming, cleaning validation, and performance studies.
• Understanding of pharmaceutical or biotechnology unit operations, manufacturing equipment, GMP requirements, and applicable CFR regulations.
• Ability to interpret engineering and automation documentation, design validation testing, evaluate validation data, and resolve technical issues.
• Strong technical writing, communication, independent prioritization, and project coordination skills.

Culture & Benefits

• Health, dental, vision, life, and disability insurance.
• Retirement and savings plan with company contributions and flexible spending accounts.
• Annual bonus program and stock-based long-term incentives.
• Paid time-off plans and career development opportunities.
• Collaborative, innovative, science-based work environment.