Lead Engineer, CSV

Purpose of the Position

The Lead CSV Engineer, Equipment Commissioning & Qualification (ECQ) supports the successful configuration, 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, this individual carries out routine tasks and functions and uses strong analytical skills to recognize and solve challenging problems of various degrees of complexity and scope.

As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

The Lead CSV Engineer, through hands‑on leadership, will be directly responsible for individual efforts, projects and other tasks. The incumbent will be responsible for fostering a productive, learning environment for colleagues and reports while ensuring timely completion of assigned work.

• Applies strong technical skillset to investigate and resolve complex challenges.
• Supports equipment qualification and validation activities.
• 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.
• Responsible for the delivery 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.

• 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 qualification, validation 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 delegate and SME in both internal and regulatory audits.

• Strong working knowledge of MS Windows client and server technologies including user groups, folder permissions and windows policies.
• Ability to learn new technologies while applying a strong technical skillset to configure computerized systems to meet Business and Regulatory requirements.
• 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…