Description

COMPANY : Legend Biotech USA, Inc

JOB TITLE : Validation Specialist

JOB DUTIES :

Execute site validation activities to the current regulatory and site requirements and address deviations associated with those activities including oversite of pre-validation and validation activities resulting from technical changes. Control Aseptic process validation and particle runs from protocol generation, training execution oversite and reporting. Support equipment process qualification and ensure consistency with process needs defined by Manufacturing or Tech Support. Support the investigation of validation/PQ/study challenges at Site. Support the establishment of KPI and own execution of routing CPV/OPV reporting. Support APQ/APQR site reporting with data analysis and evaluation. Provide technical assessments, rationales, and approval for engineering and process changes to meet regulatory requirements. Implement and evaluate raw material and consumable changes for process impact including but not limited to leachable/extractable studies and perform associated implementation studies. Implement packaging and labeling changes including related studies and validation activities. Oversee the manufacturing visual inspection program. Control the manufacturing control strategy and microbial control strategy. Assess change controls for validation impact. Establish key stakeholder relationships with internal and external stakeholders. Identify and escalate potential risk areas/shortfalls to ensure the process remains in a validated state. Work cross-functionally across Technical Operations and interface with external vendors to drive the design and implementation of automation platforms for cell therapy development and manufacturing.

MINIMUM JOB REQUIREMENTS:

Education Required: Bachelor's degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering or a related field.

Experience Required: 2 years of experience in validation or manufacturing/process/production engineer within the pharmaceutical/biopharma industry.

Special Skills Required: process validation, equipment qualification, or aseptic processing; writing or supporting Quality Risk Assessments.

JOB SITE : 1000 US-202, Raritan, NJ 08869.

WORK HOURS : 9:00 a.m. to 5:00 p.m. 5 days 40 hr/wk

SALARY : $120,000 per year

TO APPLY : E-mail CV to: Attn. E McShane: talent.acquisition@legendbiotech.com .

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice .