Senior Qualification Validation Specialist

Allogene Therapeutics•Newark, NJ

1d•Onsite

About The Position

Allogene Therapeutics is a clinical-stage biotechnology company headquartered in South San Francisco that is developing allogeneic CAR T cell products for cancer and autoimmune disease. The Senior Qualification Validation Specialist develops, implements, and manages equipment qualification and validation strategies and activities supporting cGMP Manufacturing and QC laboratories. The role ensures work is delivered on time, within budget, at the required quality level, and in compliance with regulatory requirements and applicable SOPs. This is a five-day-per-week onsite role in Newark, California.

Requirements

Bachelor’s degree.
At least 8 years of experience in equipment validation, manufacturing, MSAT, or Quality Validation.
Thorough understanding of qualification and validation requirements under ICH, GAMP 5, and 21 CFR Part 11.
Strong working knowledge of applied statistics, quality systems, and regulatory requirements across multiple health authorities.
Strong technical writing skills, including the ability to author protocols and reports.
Expertise in reviewing and writing technical reports.
Excellent communication and technical writing skills.
Proficiency with Microsoft Word, Excel, and PowerPoint.
Must be authorized to work in the United States.

Responsibilities

Support commissioning, qualification, and validation lifecycle activities, including URS, RA, IQ, OQ, PQ, final reports, and execution, for manufacturing and QC equipment.
Partner with Production and MSAT to define requirement updates and requalification activities that support process validation.
Lead resolution of complex validation and technical challenges.
Partner with Quality to translate feedback, including regulatory inspection findings and regulatory changes, into a common approach for qualification and validation activities.
Maintain an overview of equipment qualification and validation across the business and establish equipment and project priorities.
Keep activities inspection-ready ahead of internal and external audits, with the goal of avoiding critical validation observations.
Ensure validation activities comply with current company requirements and cGMP, manage associated deviations, and oversee pre-validation and validation resulting from major or complex changes.
Serve as Systems Administrator for equipment and systems, including LabVantage and MODAEM.
Support periodic review of equipment and systems.
Benchmark against external industry standards to drive best-in-class practices and share knowledge across the company.