GMP Cell Therapy Validation Specialist

BioNJ Inc.; Raritan (NJ); On-site; USD 108,000 - 132,000; Full time

Job summary

Legend Biotech is seeking a validation-focused professional to execute site validation activities, manage aseptic processing, and oversee equipment qualification ensuring alignment with regulatory requirements. You will collaborate with Manufacturing and Tech Support to address deviations, investigate validation challenges, and drive continuous improvement across KPI reporting and site programs.

The role emphasizes cross-functional work, risk assessment support, and participation in change

Qualifications

• 2 years of experience in validation or manufacturing/process engineering within the pharmaceutical/biopharma industry.
• Experience in writing or supporting Quality Risk Assessments and related regulatory activities.
• Knowledge of process validation, equipment qualification, and aseptic processing practices.

Responsibilities

• Execute site validation activities to regulatory and site requirements, addressing deviations and oversite of pre-validation and validation activities.
• Control aseptic process validation and particle runs from protocol generation, training, oversite and reporting.
• Support equipment process qualification and ensure consistency with process needs defined by Manufacturing or Tech Support.
• Support investigation of validation/PQ/study challenges at site.
• Establish KPI and own routing CPV/OPV reporting; support APQ/APQR site reporting with data analysis and evaluation.
• Provide technical assessments and approvals for engineering and process changes to meet regulatory requirements.
• Implement and evaluate raw material and consumable changes including leachable/extractable studies and implementation studies.
• Oversee packaging and labeling changes including related studies and validation activities.
• Oversee the manufacturing visual inspection program and control the manufacturing control and microbial control strategies.
• Assess change controls for validation impact; identify risk areas and escalate as needed.
• Collaborate cross-functionally with Technical Operations and external vendors to drive automation platforms for cell therapy development and manufacturing.

Skills

Process validation

Equipment qualification

Aseptic processing

Quality risk assessments

Education

Bachelor's degree in Industrial Engineering

Bachelor's degree in Manufacturing Engineering

Bachelor's degree in Mechanical Engineering

Job description

Legend Biotech is seeking a validation-focused professional to execute site validation activities, manage aseptic processing, and oversee equipment qualification ensuring alignment with regulatory requirements. You will collaborate with Manufacturing and Tech Support to address deviations, investigate validation challenges, and drive continuous improvement across KPI reporting and site programs.

The role emphasizes cross-functional work, risk assessment support, and participation in change