Legend Biotech US

Sr. CSV/CQV Specialist

Raritan, New Jersey, United States · Senior

Sponsorship not specifiedDetected 21 hours ago

ExcelSAPVendor ManagementGMPFDA RegulatoryLeadershipCommunicationCollaborationOrganizational SkillsMicrosoft Office

About the role

This position will be responsible for providing Commissioning, Qualification and Validation support to all computerized systems in the cGMP Clinical and Commercial Cell Therapy Manufacturing plant.
This individual will be responsible in handling day-to-day activities inclusive of execution, protocol management, vendor management, issues, deviations, corrections and remediation efforts of computerized systems for facility, equipment, systems and processes in support of personalized cell therapy production through safe and compliant manufacturing operations according to cGMP requirements.
This role will require CSV, CQV and engineering experience, ownership and leadership, ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CSV and CQV program to enable robust production, testing and release of product to patients.

Works with above plant center of excellence (COE) to successful implement and maintain tools, standards, policies and procedures in compliance.
Manages multiple and complex CSV and CQV projects in accordance with site requirements, provides status reports and coordinates with other departments or outside contractors/vendors to complete tasks.
Supports and/or owns technical and quality investigations, CAPAs and corrections.
Authors, owns and executes master and completed CSV/CQV protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance
Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation.

A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required.
A minimum of 8+ years relevant work experience is required with expertise in 21 CFR Part 11, 58, 210 and 211, Eudralex regulations and ICH guidelines.
Expertise in GMP compliance knowledge including knowledge of 21 CFR Part 11, EU Annex 11 among others.
Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.
Ability to quickly process complex information and often make critical decisions with limited information.
Ability to independently be responsible for a portfolio of ongoing projects.
Ability to pay attention to details and follow the procedures.
The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
Good written and verbal communication skills are required. · Ability to summarize and present results, and experience with team-based collaborations is a requirement.
Ability to work with others in a team environment.

Experience with ICH and/or 21 CFR parts 210, 211, 1271 is required and 600, 601, and 610 is preferred.

Participates in authoring Risk Assessments, FMEAs, Periodic Qualifications, Project Plans, Master Plans, and Annual Product Reviews.

This listing is sourced directly from Legend Biotech US's careers page and normalized into a canonical job model.