Senior CQV Specialist: Cell Therapy Manufacturing

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

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.