Sr. CSV/CQV Specialist

Legend Biotech is seeking a Sr. CSV/CQV Specialist as part of the Manufacturing & Supply team based in Raritan, NJ.

Role Overview

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.

Key Responsibilities

Acts as the subject matter expert (SME) for 21 CFR Parts 210, 211, 11, EU Annex 11 among others.

Works with above plant center of excellence (COE) to successful implement and maintain tools, standards, policies and procedures in compliance.

Executes the commissioning, qualification, requalification, validation and any associated activities within the plant of all computerized systems such as SAP, MES, manufacturing and laboratory equipment, BAS, EDS and other software and systems and process equipment, test equipment, facility and utility systems.

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.

Develops and performs any required remediation efforts and associated CAPA plans.

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

criteria, specifically data integrity.

Executes, owns, assesses and participates in the creation, revision and review of change controls, SOPs, and other documentation.

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

Requirements

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. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably cell therapy, testing facility, quality assurance, or manufacturing compliance.

Expertise in GMP compliance knowledge including knowledge of 21 CFR Part 11, EU Annex 11 among others.

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

Thorough knowledge and understanding of GMP data integrity standards.

Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices.

Strong interpersonal and written/oral communication skills.

Ability to quickly process complex information and often make critical decisions with limited information.

Proficient in applying process excellence tools and methodologies.

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.

Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) and current Good Tissue Practices (cGTP) related to CAR-T manufacturing or cell processing.

Ability to identify/remediate gaps in processes or systems. · Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, protocols.

Experience with TrackWise, CMMS and Maximo

Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint).

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The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.

Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.

Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.

Pay Range (Base Pay):

$110,706—$145,303 USD