Sr. CSV/CQV Specialist

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