Senior Validation Engineer, Equipment (Biotech/Pharma)

Location: Jacksonville, Florida, United States. Hybrid role requiring at least four days per week in the office, with in-office requirements potentially increasing to five days. Relocation assistance is available.

Company

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

What you will do

• Support the full equipment validation lifecycle for GMP manufacturing and quality control operations.
• Develop, execute, review, and approve validation protocols, reports, plans, requirements specifications, and qualification documentation.
• Collect and analyze validation data to maintain the validated state of equipment, systems, and processes.
• Coordinate change controls, gap assessments, investigations, corrective actions, and continuous improvement initiatives.
• Provide technical guidance and training to internal teams and contracted validation resources.
• Support audits and inspections, quality-system documentation review, raw-material release, and asset lifecycle management in the Blue Mountain RAM system.

Requirements

• Bachelor’s degree in a science or engineering field and 5+ years of relevant validation experience in a medical device or cGMP environment.
• Strong understanding of validation lifecycle principles, industry practices, FDA and EU guidelines, and GMP requirements.
• Experience performing, reviewing, and overseeing equipment qualification activities.
• Working knowledge of validation datalogger systems; Kaye or Ellab experience is preferred.
• Strong communication, organization, independent problem-solving, and cross-functional collaboration skills.
• Proficiency with standard business and technical software, spreadsheets, email systems, and basic statistical tools.

Nice to have

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

Culture & Benefits

• Mission-driven environment focused on unmet medical needs and patient outcomes.
• Medical, dental, vision, and prescription coverage.
• Wellness resources, 401(k), and ESPP savings plans.
• Paid time off, paid parental leave, and disability benefits.
• Periodic scheduled 24/7 availability is required for real-time manufacturing and service data review; this review can be performed remotely.