CQV Specialist I

Legend Biotech; Raritan (NJ); On-site; USD 81,273 - 106,669; Full time

Benefits offered by this job

Medical, dental and vision insurance

401(k) retirement plan with company match

Equity and stock options

Eight weeks of paid parental leave

Flexible spending and health savings accounts

Life and AD&D insurance

Short- and long-term disability coverage

Legal assistance and supplemental plans

Commuter benefits

Job summary

A biotechnology company in Raritan, NJ, is seeking a CQV Specialist I to support commissioning and qualification activities in their cGMP manufacturing plant. The ideal candidate should possess a Bachelor’s Degree and have a minimum of 2 years of relevant experience in an aseptic manufacturing environment, with strong communication and organizational skills. This role offers a salary range of $81,273 – $106,669 and includes comprehensive benefits such as medical insurance, a 401(k) plan, and generous paid time off.

Qualifications

• Minimum of 2 years relevant work experience; preferably in aseptic manufacturing or quality assurance.
• Knowledge of cGMP regulations and FDA/EU guidance.
• Experience in authoring documentation including SOPs and CQV protocols.

Responsibilities

• Execute commissioning, qualification, requalification, and validation activities.
• Manage multiple CQV projects; provide status reports.
• Support technical and quality investigations, CAPAs and corrections.

Skills

Interpersonal skills

Attention to detail

Organizational skills

Communication skills

Education

Bachelor's Degree in Science, Engineering or equivalent technical discipline

Tools

TrackWise

Comet

CMMS

Veeva

Maximo

Microsoft Office (Outlook, Excel, Word, PowerPoint)

Job description

Legend Biotech is seeking CQV Specialist I as part of the Technical Operations team based in Raritan, NJ.

Role Overview

This position will be responsible for providing Commissioning, Qualification and Validation support to the cGMP Clinical and Commercial Cell Therapy Manufacturing plant. It includes day‑to‑day execution, protocol management, vendor management, issue resolution, deviations, corrections, and remediation for facility, equipment, systems and processes supporting personalized cell therapy production.

Key Responsibilities

• Execute the commissioning, qualification, requalification, validation, and maintenance activities within the plant.
• Manage multiple, complex CQV projects; provide status reports and coordinate with internal departments and external contractors.
• Support and 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 ensuring regulatory, SOP, specification, and data‑integrity compliance.
• 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.
• Work collaboratively with Quality, Manufacturing Operations, Facilities & Engineering, Quality Control, Operations Technical Support, Supply Chain and Planning teams.

Requirements

• Minimum of a Bachelor’s Degree in Science, Engineering or equivalent technical discipline.
• Minimum of 2 years relevant work experience; preferably in an aseptic manufacturing facility, cell therapy, testing facility, quality assurance or manufacturing compliance.
• Knowledge of cGMP regulations and FDA/EU guidance for cell‑based product manufacturing and Good Tissue Practices.
• Strong interpersonal, written and oral communication skills.
• Ability to quickly process complex information and make critical decisions with limited data.
• Proficiency in applying process excellence tools and methodologies.
• Strong organizational skills and ability to work independently on a portfolio of ongoing projects.
• Attention to detail and adherence to procedures.
• Experience with ICH and/or 21 CFR parts 210, 211, 1271, 600, 601, and 610 (preferred).
• Experience authoring and executing documentation including batch records, SOPs, work instructions and CQV protocols.
• Experience with TrackWise, Comet, CMMS, Veeva, and Maximo.
• Proficiency with Microsoft Office (Outlook, Excel, Word, PowerPoint).
• English language proficiency.

The anticipated base pay range is $81,273 USD – $106,669 USD.

Benefits

• Medical, dental and vision insurance
• 401(k) retirement plan with company match that vests fully on day one
• Equity and stock options in eligible roles
• Eight weeks of paid parental leave after three months of employment
• Paid time off: 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays and 3 floating holidays
• Flexible spending and health savings accounts
• Life and AD&D insurance
• Short‑ and long‑term disability coverage
• Legal assistance and supplemental plans (pet, critical illness, accident, hospital indemnity)
• Commuter benefits, family planning and care resources, well‑being initiatives, and peer‑to‑peer recognition programs

EEO Statement

Legend Biotech is a proud equal‑opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. We prohibit discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by applicable law.

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

Legend Biotech maintains a drug‑free workplace.