Manager, CSV Cell Therapy

Position Summary

Manager, CSV Cell Therapy supports implementation and support of manufacturing/laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers.

• Support equipment qualification and validation activities.
• Investigate and resolve Deviations and CAPA investigations.
• Configure and document computerized systems to meet CFR
  21 Part 11 requirements.
• Execute equipment qualification and validation protocols.
• Supervise vendors for qualification functions.
• Complete qualification/validation documentation with accuracy and compliance to Celgene standards.
• Own lifecycle deliverables for equipment qualification and CSV for single and multi-user computerized systems.
• Develop validation/qualification deliverables (e.g., Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls).
• Initiate/manage projects of moderate scope and varying complexity; supervise/direct team members.
• Author quality procedures and training documents; deliver training and best practices.
• Innovate and develop tools/solutions for more efficient and compliant outcomes.
• Support equipment implementation (scheduling, procurement, site prep, installation, qualification, turnover).
• Support standardization of review/approval of validation deliverables.
• Provide customer service/support; respond to qualification/support requests; provide technical guidance.
• Ensure compliance of equipment/facilities/programs; act as departmental lead/SME in audits.

• Excellent understanding of cGXP and documentation practices.
• Strong knowledge of ISPE guidance and 21 CFR Part 11; SDLC principles.
• Ability to identify/document user and functional requirements.
• Knowledge of pharmaceutical lab/manufacturing systems; experience executing equipment qualification documents.
• Ability to interface with manufacturing, lab, QA, Facilities.
• Proficient MS Windows client/server;
  Microsoft Office (Word, Excel, Visio, Outlook); technical writing.
• Strong communication, organization, multi-tasking, and troubleshooting skills.

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

• Health coverage (medical, pharmacy, dental, vision).
• Wellbeing support (programs/EAP).
• 401(k), disability and life insurance, and other listed protection benefits.
• Paid time off (flexible time off for US Exempt; vacation/holidays for other listed groups).