Validation Specialist

Full Timejunior

Raritan, New Jersey, United StatesPosted 14 days ago

Role Overview

Legendcareers is hiring a entry-level Validation Specialist. This is a full-time role in Raritan, New Jersey. posted 2 weeks ago. Full responsibilities, required qualifications, and the apply link are listed in the description below.

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Job description

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.

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.

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):

$86,944—$86,944 USD

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.

About Legendcareers

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Frequently Asked Questions

How do I apply for the Validation Specialist position at Legendcareers?

Use the Apply button above to submit your application directly to Legendcareers. Most applications take less than 5 minutes if your resume and contact details are ready, and you'll be routed to the employer's official application system to finish.

Where is the Validation Specialist position at Legendcareers located?

This position is based in Raritan, New Jersey. Legendcareers has not indicated remote or hybrid options for this role, so candidates should plan for on-site work.

What does a Validation Specialist at Legendcareers earn?

Legendcareers has not disclosed a salary range in this posting. Many employers share specifics later in the interview process; you can also ask during a recruiter screen if compensation transparency is important to you.

When was the Validation Specialist role at Legendcareers posted?

This role was posted on June 26, 2026 (14 days ago). It's still listed as actively hiring; we re-confirm openings against the source system multiple times per day and remove closed roles.

Is the Validation Specialist role at Legendcareers entry-level?

Yes. This is an entry-level position. Strong candidates typically have 0-2 years of relevant work experience, internships, or significant project work. Read the full description for any specific qualification requirements Legendcareers has listed.