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

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 escalation 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

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

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life‑threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR‑T), T-cell receptor (TCR‑T), natural killer (NK) cell‑based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting‑edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta‑cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I‑9 process, and your employment eligibility will be verified through E‑Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

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.

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