Sr. CSV/CQV Specialist (Biotech)

TL;DR

Sr. CSV/CQV Specialist (Biotech): Providing commissioning, qualification, and validation support for computerized systems in a cGMP cell therapy manufacturing plant with an accent on regulatory compliance and data integrity. Focus on managing complex CSV/CQV projects, executing protocols, and ensuring robust production standards for life-saving therapies.

Location: Must be based in Raritan, NJ (Onsite)

Salary: $110,706 - $145,303 USD

Company

hirify.global is a global biotechnology company developing advanced cell therapies, including CAR-T and NK cell-based immunotherapies, to treat life-threatening diseases.

What you will do

• Act as the subject matter expert for 21 CFR Parts 210, 211, 11, and EU Annex 11.
• Execute commissioning, qualification, and validation activities for computerized systems, including SAP, MES, and manufacturing equipment.
• Manage complex CSV and CQV projects, providing status reports and coordinating with cross-functional teams and vendors.
• Own technical and quality investigations, CAPAs, and remediation efforts.
• Author and execute master CSV/CQV protocols, summary reports, and data integrity assessments.
• Participate in risk assessments, FMEAs, and the review of change controls and SOPs.

Requirements

• Bachelor’s Degree in Science, Engineering, or equivalent technical discipline.
• 8+ years of relevant work experience with expertise in 21 CFR Part 11, 58, 210, 211, and ICH guidelines.
• Thorough knowledge of cGMP and cGTP regulations related to cell-based products.
• Experience with TrackWise, CMMS, and Maximo.
• Must be able to work onsite in Raritan, NJ.
• Strong interpersonal and communication skills with the ability to work in a team environment.

Culture & Benefits

• Comprehensive medical, dental, and vision insurance.
• 401(k) retirement plan with company match vesting on day one.
• Eight weeks of paid parental leave after three months of employment.
• Generous paid time off policy including vacation, personal, sick, and floating holidays.
• Access to well-being initiatives, family planning resources, and peer-to-peer recognition programs.