Manager, Computer System Validation (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. This individual carries out routine tasks and functions, uses strong analytical skills to recognize and solve common problems of various degrees of complexity and scope, and through hands-on leadership is directly responsible for individual and team-based efforts, projects, and other tasks.

Duties/Responsibilities

• 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 CFR21 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, Change Controls.
• Initiates, manages, and leads projects of moderate scope and complexity within their functional area.
• Supervise and direct 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.
• Deliver training on procedures and best practice to an audience that may include departmental personnel and business partners.
• Innovate, research and develop 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 turn over to business area.
• Support growing standardization efforts in the review and approval of Validation Deliverables.
• 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.

Regulatory Responsibilities

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

Qualifications

• 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.
• Strong written and verbal communication skills along solid presentation skills.
• Experience with technical writing and document development / generation.
• Strong computer skills in Microsoft Office Suite – Word, Excel, Visio and Outlook, and the ability to learn new software as required for equipment qualification.

Education/Experience

• BS degree or equivalent experience.
• Minimum 5 years of experience in FDA-regulated industry.