Quality Assurance Validation Engineer (mRNA)

Location: Waltham, Massachusetts, United States; onsite. This is a US-based role.

Salary: $78,000–$112,666.66 per year.

Company

hirify.global is an R&D-driven biopharmaceutical company developing medicines, vaccines, mRNA platforms, and AI-enabled healthcare technologies.

What you will do

• Provide QA oversight for GMP validation activities across facilities, utilities, systems, equipment, and computer systems.
• Support validation project plans, protocols, field activities, data analysis, final reports, and project closeout.
• Partner with Validation, Automation, Metrology, Quality Control, Business System Owners, and other QA functions.
• Review and approve procedures, deviations, CAPAs, change controls, investigations, and remediation activities.
• Act as the QA subject matter expert for equipment, instruments, data integrity, metrology, and automation.
• Support continuous improvement, quality systems development, audits, inspections, and regulatory compliance.

Requirements

• Bachelor’s degree in mechanical engineering, chemical engineering, computer science, or a related field relevant to biotechnology or pharmaceuticals.
• At least 3 years of experience in validation within the pharmaceutical, biologics, or medical device industry.
• At least 3 years of experience with facility startups, factory or site acceptance testing, commissioning, qualification, and related documentation.
• Experience with validation protocols, project plans, data analysis, final reports, asset management, and NIST traceability.
• Experience working under US, EU, and ICH GMP requirements, including audits and regulatory inspections.
• Strong written, verbal, interpersonal, and cross-functional collaboration skills.

Nice to have

• Experience supporting early-phase clinical programs and Phase I/II companies through commercialization.

Culture & Benefits

• Work on mRNA innovation, smart manufacturing, AI-driven research, and vaccine development.
• Career growth opportunities through promotions, lateral moves, mentoring, and international mobility programs.
• Healthcare, prevention, wellness, and family benefits, including at least 14 weeks of gender-neutral parental leave.
• Eligibility for company employee benefit programs and a rewards package based on contribution.
• US-based employees must be fully vaccinated against COVID-19 as part of their job responsibilities.