Principal Validation Engineer (Pharmaceutical Manufacturing)

Location: Albuquerque, NM, United States; onsite role in a sterile pharmaceutical manufacturing environment.

Company

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

What you will do

• Serve as the senior Validation SME for NPI and technology transfer programs from project initiation through commercial launch.
• Develop and approve validation strategies, master plans, risk assessments, protocols, reports, and lifecycle documentation.
• Lead validation assessments, fit-gap analyses, risk assessments, operational readiness reviews, and technical investigations.
• Provide validation leadership for process, cleaning, equipment, utility, facility, sterilization, computerized systems, and aseptic process validation.
• Partner with Program Management, Manufacturing, Quality, Regulatory Affairs, Engineering, Technical Operations, customers, and other functions.
• Support PPQ campaigns, commercial manufacturing, regulatory inspections, customer audits, change controls, CAPAs, training, and continuous improvement.

Requirements

• Bachelor’s degree in Science, Engineering, or a related technical discipline plus at least 12 years of validation, technology transfer, manufacturing science, or process engineering experience in sterile pharmaceutical manufacturing; or a Master’s degree plus at least 10 years of the same experience.
• Advanced expertise in validation principles within a sterile pharmaceutical manufacturing environment.
• Strong technical writing skills for authoring validation documentation.
• Ability to work semi-independently, manage multiple projects and priorities, and collaborate across technical departments.
• Excellent communication, presentation, influencing, leadership, and collaboration skills.
• Ability to read, interpret, and implement technical writing, SOPs, regulatory requirements, and instructions.
• Must pass a background check and drug screen; occupational health screening may be required.
• Gowning certification, media qualification, and respirator use may be required.

Nice to have

• NPI and technology transfer experience.
• Process validation and cleaning validation program leadership.
• Experience supporting PPQ campaigns and commercial product launches.
• Experience with aseptic processing, sterilization validation, facility qualification, and critical utility qualification.
• Experience interacting with customers and regulatory agencies.
• Working knowledge of FDA, EU GMP, Annex 1, Annex 11, PIC/S, ISPE, PDA, and GAMP principles.

Culture & Benefits

• Full-time position with cross-functional collaboration and mentoring responsibilities, without direct supervisory responsibility.
• Benefits are available from the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins on the first day.
• 401K program with matching contributions, education reimbursement, and access to a learning platform.
• Career advancement opportunities and a focus on safety, collaboration, and continuous improvement.

Hiring process

• Apply online; applications from unsolicited headhunters or recruitment firms are not accepted.
• Employment offers may consider education, experience, location, tenure, and internal equity.