Manager, CSV Cell Therapy

Position Summary

The Manager, CSV Cell Therapy supports the successful implementation and support of manufacturing and laboratory equipment and computerized systems at multi‑use sites through interaction with internal customers and external service providers. With minimum supervision and given general instructions, the incumbent carries out routine tasks and functions, and uses strong analytical skills to recognize and solve common problems of various degrees of complexity and scope.

• Supports equipment qualification and validation activities.
• Investigate and resolve Deviations, CAPA investigations and other potential issues.
• Configure and document the configuration of computerized systems to meet the requirements of CFR
  21 Part 11.
• Supports the execution of equipment qualifications and validation protocols.
• Supervises vendors for qualification functions.
• Completes all qualification and validation documentation with accuracy, completeness, and compliance to Celgene standards.
• Independent ownership of all lifecycle deliverables in the qualification of equipment and full CSV for single and multi‑user Computerized Systems.
• Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, and Change Controls.
• Initiates, manages, and leads projects of moderate scope and complexity within the functional area.
• Supervises and directs other team members to ensure completion of objectives.
• Manages projects of varying scope and complexity.
• Maintains a positive relationship with all team members and site customers while promoting a positive learning, team environment.
• Author quality procedures and training documents.
• Delivers training on procedures and best practice to an audience that may include departmental personnel and business partners.
• Innovates, researches, and develops tools and solutions to provide more efficient and compliant solutions for department use and deployment.
• Supports laboratory and manufacturing equipment implementation projects including scheduling, procurement, site prep, installation, qualification, and turnover to business area.
• Supports growing standardization efforts in the review and approval of Validation Deliverables.
• Promotes and provides excellent customer service and support.
• Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
• Provides technical support and guidance on Validation, Quality Process, and equipment qualification issues.
• Interfaces with customers to ensure all expectations are being met.

• Ensure equipment, facilities and programs are maintained in compliance.
• Act as departmental lead and SME in both internal and regulatory audits.

• Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry.
• Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance.
• Strong working knowledge of SDLC principles and standards.
• Ability to work with the end user 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, QA, and Facilities groups.
• Strong working knowledge of MS Windows client and server technologies.
• Strong ability to organize assigned tasks in a high‑paced environment and concurrently monitor tasks/assignments with others that may impact timely completion.
• Ability to effectively manage multiple tasks and activities simultaneously.
• Strong written and verbal communication skills along solid presentation skills.
• Proficient at writing well‑formulated emails and reports.
• Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task.
• Ability to effectively communicate with employees, contractors, and vendors.
• Experience with technical writing and document development/generation.
• Strong computer skills in Microsoft Office…