Lead Engineer, CSV Summit West - NJ - US R1602403

## Lead Engineer, CSVSummit West - NJ - USFind out how well you match with this job
** Working with Us
** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more:
** 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.
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* Essential Functions:

**** Maintains all qualified and validated equipment and systems in compliance with policies, guidelines and procedures:
*** Applies strong technical skillset to investigate and resolve complex challenges.  + Investigate and resolve Deviations, CAPA investigations and other potential issues.
* 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.
** Initiates, manages and leads projects of moderate scope and complexity within their functional area.
*** 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
** Promotes and provides excellent customer service and support
*** Provides excellent customer service and support.
* Regularly reviews, prioritizes and…