Validation Engineer IV (NPI)

Location: Albuquerque, NM, United States; full-time, onsite role.

Company

hirify.global is a global contract development and manufacturing organization supporting pharmaceutical and biotech companies with drug development, technology transfer, and manufacturing services.

What you will do

• Serve as the functional subject matter expert for NPI and technology transfer projects from initiation through commercial launch.
• Lead discipline-specific assessments, gap analyses, risk evaluations, readiness reviews, stage-gate deliverables, and knowledge transfer.
• Develop, execute, review, and approve complex validation protocols for computer systems, manufacturing and packaging equipment, cleanrooms, aseptic processing, sterilization systems, utilities, and lyophilizers.
• Author and maintain validation master plans, analyze testing data, prepare technical reports, and recommend corrective actions.
• Coordinate validation activities with Program Management, Operations, Quality, Regulatory, customers, vendors, and consultants.
• Support inspections, audits, investigations, deviations, technical training, plant readiness, requalification, and continuous improvement.

Requirements

• Bachelor’s degree in science, engineering, or a relevant field and at least 8 years of pharmaceutical validation experience in an aseptic or sterile product environment, or a master’s degree in a relevant field and at least 6 years of such experience.
• Experience with validation tools and processes, including temperature mapping and Kaye Validator or Ellab Loggers.
• Knowledge of FDA and EU pharmaceutical regulations and validation requirements, including cGMP, ISO 9000-3, PIC/S guidelines, GAMP 4 and 5 based on the GAMP V-Model Framework, and EU GMP Annex 11.
• Advanced technical writing and mathematics skills, including calculus, with strong attention to detail.
• Ability to read and interpret SOPs, maintain current training, provide technical guidance, and mentor team members.
• Must pass a background check and drug screen; occupational health screening may be required.
• Must obtain and maintain gowning certification; media qualification may be required.
• May be required to wear a respirator.

Culture & Benefits

• Benefits are available from the first day of employment and include medical and other benefit options.
• Paid training, vacation, and holidays; vacation accrual begins on the first day of employment.
• 401(k) program with matching contributions and education reimbursement.
• Career advancement opportunities and access to a learning platform.
• Collaborative, safety-focused environment that supports mentoring, change, and continuous improvement.

Hiring process

• All interested applicants must apply online.
• hirify.global does not accept unsolicited assistance from headhunters or recruitment firms without a valid, signed agreement for the specific position.