Senior Quality Validation Specialist

Location: Bridgewater, New Jersey, United States; on-site

Company

hirify.global operates an IDMO facility focused on regulated biotechnology, cell, and gene therapy operations.

What you will do

• Review and approve complex GMP documentation, including validation and CSV protocols, reports, risk assessments, SOPs, CAPAs, and deviations.
• Author and maintain the IDMO Site Validation Plan and provide Quality oversight of process validation studies and process performance qualifications.
• Oversee cleanroom lifecycle programs, including aseptic process simulations, environmental monitoring qualification, certification, cleaning, sanitization, and facility controls.
• Identify and resolve technical and compliance gaps while ensuring adherence to facility and equipment control procedures.
• Collaborate with internal and external stakeholders, communicate system and facility status, and monitor project progress.
• Serve as a Quality Engineering subject matter expert during client and regulatory inspections and drive continuous improvement.

Requirements

• Bachelor’s degree in a scientific or engineering discipline.
• 5–8 years of experience in a GMP environment within pharmaceutical, biologics, vaccine, cell therapy, or gene therapy operations.
• At least 2 years of direct experience in quality or validation, with knowledge of relevant cGMP regulations.
• Strong knowledge of GMP, global biotechnology regulations, cell and gene therapy products, Regulatory CMC, and Quality by Design.
• Comprehensive understanding of risk management, CAPA processes, and complex scientific issues related to regulatory requirements and strategy.
• Experience with on-site regulatory inspections is desirable; computerized systems validation experience is a plus.

Culture & Benefits

• Full-time role in a fast-paced, mission-driven environment.
• Work within a regulated IDMO facility and collaborate across multiple technical and Quality functions.
• Leveling is based on overall experience, education, and demonstrated knowledge during the interview process.