Validation Specialist

Job Title Validation Specialist. Company Overview Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life‑threatening diseases. Headquartered in Somerset, New Jersey, we develop 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. Job Duties Execute site validation activities to current regulatory and site requirements, address deviations including oversight of pre‑validation and validation activities from technical changes. Control aseptic process validation and partial runs from protocol generation, training execution, oversight, 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. Support 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 leachable/extractable studies and 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 elevate 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 design and implementation of automation platforms for cell therapy development and manufacturing. Minimum Job Requirements Education: Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering, or related field. Experience: 2 years in validation or manufacturing/process/production engineering within the pharmaceutical/biopharma industry. Special Skills: 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 a week (40 hours per week). Compensation Base pay range: $86,944 - $86,944 USD (actual compensation may vary based on experience, skills, qualifications, and geographic location). Other types of pay: Performance‑based bonus and/or equity available. Benefits Medical, dental, and vision insurance. 401(k) retirement plan with company match that vests fully on day one. Eight weeks paid parental leave after three months employment. Paid time off: vacation time, personal time, sick time, floating holidays, and eleven company holidays. Voluntary benefits: flexible spending and health savings accounts, life and AD&D insurance, short‑ and long‑term disability coverage, legal assistance, supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. Voluntary commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs. Benefits are offered exclusively to permanent full‑time employees. Contractors are not eligible for benefits. 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. At‑Will Employment Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. #J-18808-Ljbffr Legend Biotech US