Sr. CQV Specialist

Legend Biotech; Raritan (NJ); On-site; USD 107,482 - 141,070; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid parental leave

Flexible spending accounts

Life and AD&D insurance

Job summary

A leading biotechnology company is seeking a Sr. CQV Specialist in Raritan, NJ. This role supports the cGMP Cell Therapy Manufacturing plant, focusing on validation and compliance. Responsibilities include executing CQV protocols, managing projects, and supporting technical investigations. Candidates should have a Bachelor’s degree, 7+ years of experience in aseptic manufacturing, and proficiency with Microsoft ERP and testing systems. Competitive compensation and comprehensive benefits are offered, including a performance bonus and equity.

Qualifications

• Minimum 7 years relevant work experience.
• Preferred experience in an aseptic manufacturing facility, preferably cell therapy.
• Proficient in process excellence tools and methodologies.

Responsibilities

• Execute CQV validation and requalification activities within the plant.
• Manage multiple CQV projects and collaborate with cross-functional teams.
• Support technical and quality investigations, CAPAs, and corrections.

Skills

Interpersonal skills

Communication skills

Project management

Attention to detail

Decision making

Education

Bachelor’s Degree in science or engineering

Tools

Microsoft suite

ERP systems (Maximo, Siemens EMS, Comet, Kneat)

Testing systems (Kaye AVS, Kaye Valprobe)

Job description

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. From our three R&D sites worldwide, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting‑edge therapeutics for patients worldwide.

Role Overview

This Sr. CQV Specialist will provide Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant in Raritan, NJ. The role requires day‑to‑day execution of protocol management, vendor management, issue resolution, deviations, corrections and remediation efforts for facility, equipment, systems and processes in support of personalized cell therapy production. The specialist will represent CQV work in regulator and internal audits and independently drive effective communication and coordination across relevant cross‑functional groups to establish a strong, compliant CQV program enabling robust production, testing and release of product to patients.

Key Responsibilities

• Execute commissioning, qualification, requalification, validation and associated maintenance activities within the plant.
• Manage multiple and complex CQV projects, collaborating with cross‑functional teams, providing status reports and coordinating with other departments or external contractors/vendors to complete tasks.
• Support or own technical and quality investigations, CAPAs and corrections.
• Develop and perform remediation efforts and associated CAPA plans.
• Author, own and execute master and completed CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria, specifically data integrity.
• Execute, own, assess and participate in the creation, revision and review of change controls, SOPs, and other documentation.
• Participate in authoring risk assessments, FMEAs, periodic qualifications, project plans, master plans and annual product reviews.
• Train and support junior team members on different CQV activities.
• CQV work to regulatory and internal audit teams.
• Make decisions on technical approach, methodology per applicable procedure.
• Manager approval required for resource assignment, timeline shift, strategic shift and finance related events.

Requirements

• A minimum of a Bachelor’s Degree in science, engineering or equivalent technical discipline.
• A minimum of 7 years relevant work experience. Preferred experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance or manufacturing compliance.
• Proficiency with Microsoft suite and ERP systems (Maximo, Siemens EMS, Comet, Kneat) and testing systems (Kaye AVS, Kaye Valprobe).
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell‑based products and Good Tissue Practices.
• Strong interpersonal and written/oral communication skills.
• Ability to process complex information quickly and make critical decisions with limited information.
• Proficiency in applying process excellence tools and methodologies.
• Independent management of a portfolio of ongoing projects.
• High organization and team‑environment capacity with a positive attitude under some supervision.
• Experience authoring and executing documentation including batch records, SOPs, work instructions and CQV protocols.

Compensation

Base pay range: $107,482 USD – $141,070 USD. Performance‑based bonus and/or equity is available to employees in eligible roles.

Benefits

Medical, dental, and vision insurance; 401(k) retirement plan with company match vesting fully on day one; eight weeks of paid parental leave after three months of employment; paid time‑off policy including vacation, personal, sick, floating holidays, and eleven company holidays; 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; commuter benefits; family planning and care resources; well‑being initiatives; and peer‑to‑peer recognition programs.EEO Statement

Legend Biotech provides 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.

General

Employment is at‑will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions.