CQV Specialist I — Cell Therapy Manufacturing

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

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.