Validation Specialist

Legend Biotech EU; Raritan (NJ); Presencial; USD 108.000 - 132.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, and vision insurance

401(k) with company match

8 weeks parental leave

Paid time off

Disability coverage

Well-being programs

Descripción de la vacante

Legend Biotech USA, Inc. in Bridgewater, New Jersey, is seeking a Validation Specialist to lead site validation activities and ensure regulatory compliance across manufacturing and process changes.

The role involves overseeing equipment qualification, aseptic processing, and cross-functional support with Manufacturing and Tech Support teams. The position offers a competitive base salary, opportunities for bonus/equity, and comprehensive benefits.

Formación

• Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering or related field.
• 2 years of experience in validation or manufacturing/process/production engineer within the pharmaceutical/biopharma industry.
• Special Skills: process validation, equipment qualification, or aseptic processing; writing or supporting Quality Risk Assessments.

Responsabilidades

• Execute site validation activities to current regulatory and site requirements.
• Oversee pre-validation and validation activities from protocol generation, training execution, and reporting.
• Support equipment qualification and ensure consistency with process needs defined by Manufacturing or Tech Support.
• Investigate validation/PQ/study challenges at Site and support KPI reporting.
• Provide technical assessments and approvals for engineering and process changes to meet regulatory requirements.
• Implement and evaluate changes to raw materials, consumables, packaging, labeling, and related validation studies.
• Oversee the manufacturing visual inspection program and control strategies.
• Engage cross-functionally with Technical Operations and vendors to advance automation platforms for cell therapy development and manufacturing.

Conocimientos

process validation

equipment qualification

aseptic processing

quality risk assessments

Educación

Bachelor’s degree in Industrial Engineering, Manufacturing Engineering, Mechanical Engineering or related field

Descripción del empleo

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.

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 particular 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 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 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 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

The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay)

$120,000—$120,000 USD

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

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.

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