Assoc III, Validation

Location: Round Lake, Illinois, United States. Applicants must be authorized to work for any employer in the U.S.; visa sponsorship is not available.

Salary: $96,000–$132,000 annually, with potential discretionary bonuses.

Company

hirify.global develops healthcare products and solutions focused on improving patient care and sustaining lives.

What you will do

• Provide Quality Assurance leadership for complex, risk-based validation projects.
• Review and approve validation plans, protocols, reports, risk assessments, change controls, and revalidation documentation.
• Partner with R&D, Manufacturing, Engineering, and Quality teams on new product introductions and commercial manufacturing readiness.
• Lead the site Data Integrity Governance Program in alignment with GAMP 5, 21 CFR Part 11, ALCOA+ principles, and regulatory requirements.
• Govern computerized systems through periodic reviews, audit trail requirements, user access management, and remediation monitoring.
• Lead investigations, monitor program metrics, support inspections and audits, and drive continuous improvement.

Requirements

• Bachelor’s degree in Engineering, Science, Computer Science, or a related technical field.
• 5+ years of experience in Quality Assurance, validation, computerized systems, data integrity, or a related field in pharmaceutical, biotechnology, or medical device manufacturing.
• Strong knowledge of validation lifecycle management, computerized systems, data integrity, risk management, cGMP, and applicable regulations.
• Experience approving validation documentation, assessing compliance risks, leading cross-functional initiatives, and managing investigations.
• Experience supporting regulatory inspections and direct interaction with regulatory agencies.
• ASQ CQE, CSQE, CQA, or equivalent certification is required.

Nice to have

• Experience leading site-wide data integrity or computerized system governance programs.

Culture & Benefits

• Medical and dental coverage begins on the first day.
• Life, disability, accident, and business travel insurance are available.
• 401(k) retirement savings plan with company matching and an Employee Stock Purchase Plan.
• Educational assistance, paid holidays, paid time off, family and medical leave, and paid parental leave.
• Additional benefits include commuting support, childcare benefits, employee discounts, and an employee assistance program.