Manager, Computer System Validation (CSV) - Summit West NJ
About The Position
The Manager, CSV Cell Therapy supports the implementation and ongoing support of manufacturing and laboratory equipment and computerized systems at multi-use sites, working with internal customers and external service providers. With general instructions and minimum supervision, the role performs routine functions, applies analytical skills to solve problems, and collaborates with the immediate team and broader organization. Through hands-on leadership, the manager is responsible for individual and team projects and tasks, supports colleagues’ learning and development, and ensures assigned work is completed on time. The role maintains qualified and validated equipment and systems in compliance with applicable policies, guidelines, procedures, and regulatory requirements. It leads projects of moderate scope, supports customer needs, and serves as a departmental subject matter expert in internal and regulatory audits. The position is primarily office-based and also requires entering laboratory or GMP process areas while wearing appropriate gowning, lab coats, or PPE.
Requirements
- Bachelor of Science degree or equivalent experience.
- At least 5 years of experience in an FDA-regulated industry.
- Excellent understanding of cGXP requirements and good documentation practices for pharmaceutical systems, equipment, and instrumentation.
- Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.
- Strong working knowledge of SDLC principles and standards.
- Ability to work with end users to identify and document user and functional requirements.
- Knowledge of pharmaceutical laboratory and manufacturing systems.
- Experience executing equipment qualification documents.
- Ability to interact effectively with manufacturing, laboratory, Quality Assurance, and Facilities groups.
- Strong working knowledge of Microsoft Windows client and server technologies.
- Ability to organize and manage multiple concurrent tasks in a fast-paced environment, including monitoring assignments that may affect timely completion.
- Strong written, verbal, and presentation skills, including writing emails, reports, and technical documentation.
- Ability to follow oral and written instructions and interpret relevant engineering manuals and drawings.
- Ability to communicate effectively with employees, contractors, and vendors.
- Strong computer skills in Microsoft Office Suite, including Word, Excel, Visio, and Outlook, and ability to learn new software as needed.
- Competencies include technical and professional knowledge, problem solving and troubleshooting, action orientation, attention to detail, multitasking, and relationship building.
- Ability to occasionally stoop, bend, stretch, push, pull, reach, and lift up to 25 pounds.
- Ability to sit, stand, walk, and move within the workspace for extended periods and perform repetitive hand and finger tasks, including grasping, pushing, and pulling.
- Ability to work safely and effectively alone or with others.
Responsibilities
- Support equipment qualification and validation activities, including execution of qualification and validation protocols.
- Investigate and resolve deviations, CAPA investigations, and other potential issues.
- Configure computerized systems and document configurations to meet 21 CFR Part 11 requirements.
- Supervise vendors performing qualification functions.
- Complete qualification and validation documentation accurately, completely, and in compliance with company standards.
- Own lifecycle deliverables for equipment qualification and CSV of single- and multi-user computerized systems.
- Develop validation and qualification deliverables, including validation plans, requirements specifications, protocols, traceability matrices, summary reports, and change controls.
- Initiate, manage, and lead projects of moderate scope and complexity; manage projects of varying scope and complexity.
- Supervise and direct team members to ensure objectives are completed.
- Promote positive working relationships and a productive learning and team environment.
- Author quality procedures and training documents, and deliver training on procedures and best practices.
- Research and develop tools and solutions that improve department efficiency and compliance.
- Support laboratory and manufacturing equipment implementation, including scheduling, procurement, site preparation, installation, qualification, and handover to the business area.
- Support standardization efforts through review and approval of validation deliverables.
- Review, prioritize, and respond promptly to customer equipment qualification and support requests.
- Provide technical guidance on validation, quality processes, and equipment qualification, and work with customers to meet expectations.
- Ensure equipment, facilities, and programs are maintained in compliance.
- Act as departmental lead and subject matter expert during internal and regulatory audits.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
