Senior Quality Engineer (Biotech)

Location: Jacksonville, Florida, United States; hybrid role requiring at least four days per week in the office, with attendance potentially increasing to five days.

Company

hirify.global develops pharmaceutical therapies for rare diseases and technologies intended to expand the availability of transplantable organs.

What you will do

• Coordinate equipment, system, and process validation activities across Manufacturing, Quality Control, Quality Assurance, Operations, and R&D.
• Develop, execute, review, and support approval of validation plans, requirements specifications, protocols, reports, and lifecycle documentation.
• Collect, analyze, and interpret validation data to confirm and maintain the validated state of equipment for GMP use.
• Evaluate validation-related change controls, perform gap assessments and root cause analyses, and coordinate corrective and continuous improvement actions.
• Provide technical guidance and training to internal and contracted personnel and serve as the onsite contact for contracted validation services.
• Support quality system activities, regulatory audits and inspections, documentation review, raw material release, investigations, complaints, SOP updates, and asset lifecycle management in Blue Mountain RAM.

Requirements

• Bachelor’s degree in a science or engineering field.
• At least five years of relevant validation experience in a medical device or cGMP environment.
• Strong understanding of validation lifecycle principles, industry practices, FDA and EU validation and GMP guidelines, and applicable quality requirements.
• Experience performing, reviewing, and overseeing equipment qualification activities, including validation protocols and reports.
• Working knowledge of validation datalogger systems; Kaye or Ellab experience is preferred.
• Strong communication, organization, independent-working, prioritization, and technical documentation skills.

Nice to have

• Experience with computerized information systems and manufacturing control systems such as BMS, DCS, and SCADA.

Culture & Benefits

• Periodic scheduled 24/7 availability is required for real-time manufacturing and service data review; this review can be completed remotely.
• Eligible employees may receive medical, dental, vision, and prescription coverage.
• Benefits include wellness resources, 401(k), ESPP, paid time off, paid parental leave, and disability coverage.
• The organization focuses on innovative therapies and technologies addressing unmet medical needs.