Senior Instrumentation Technical Lead 8/31/2016

Bristol-Myers Squibb Syracuse, NY

Company
Bristol-Myers Squibb
Job Classification
Full Time
Company Ref #
29379174
AJE Ref #
576045764
Location
Syracuse, NY
Job Type
Regular

JOB DESCRIPTION

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The Syracuse Quality Control (SQC) Laboratories support the onsite small scale commercial manufacturing facility, as well as network and third party manufacturing facilities. The Logistics group provides operational and technical support to the QC laboratory by enabling continued daily operations in the testing laboratories to meet customer needs. . The Senior Technical Lead, Instrumentation oversees the instrument management team by ensuring processes are in place to support the lifecycle management of instrumentation, provides technical leadership in handling instrumentation issues, and partners with all levels of laboratory personnel, Validation Services, Quality Assurance and Facilities & Engineering to ensure efficient and compliant processes are in place.

The Syracuse Quality Control (SQC) Laboratories support the onsite small scale commercial manufacturing facility, as well as network and third party manufacturing facilities. The Logistics group provides operational and technical support to the QC laboratory by enabling continued daily operations in the testing laboratories to meet customer needs.

The Senior Technical Lead, Instrumentation oversees the instrument management team by ensuring processes are in place to support the lifecycle management of instrumentation, provides technical leadership in handling instrumentation issues, and partners with all levels of laboratory personnel, Validation Services, Quality Assurance and Facilities & Engineering to ensure efficient and compliant processes are in place.

DUTIES/RESPONSIBILITIES:

* Coordinate the management and execution of day to day activities of the instrument management team to ensure activities are aligned with department needs.
* Collaborate with validation services, laboratory personnel and quality assurance to ensure alignment on priority for instrumentation activities, including qualification, validation, modification, and retirement.
* Initiate and drive change controls and associated pre and post implementation requirements to completion for instrumentation.
* Maintain/develop 5year instrumentation plan for the department and assist with annual department budget.
* Lead/drive operational excellence activities to improve process and systems for instrumentation that may involve cross-functional team.
* Develop/Maintain processes to ensure effective communication with Laboratory Equipment Maintenance teams to ensure coverage of calibration, preventative maintenance and repair of laboratory instrumentation
* Review and approve instrument qualification and computer software/hardware validation protocols and final reports in conjunction with department subject matter experts, validation services, and quality assurance. Execute computer system validation test scripts. Author documentation as business needs require.
* Review and approve periodic reviews of computer system validation and instrument qualifications.
* Maintain/develop systems to ensure comprehensive inventory of instrument and equipment with the laboratory and status.
* Coordinate and oversee the qualification adhere to scheduled timelines while maintaining flexibility.
* Contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.

EDUCATION/EXPERIENCE/ LICENSES/CERTIFICATIONS:

* Minimum of BS in relevant computer or scientific area with 7years' experience, MS degree with 4years' experience or PhD with limited or no experience in the biopharmaceutical industry.

PHYSICAL DEMANDS/ WORK ENVIRONMENT:

* This position is a primarily an office based position, however, requires routine entry into laboratories to access instrumentation which requires appropriate levels of personal protective equipment (PPE).
* Frequent repeated motions such as lifting, bending, twisting, squatting, walking, climbing on step-stools, and reaching is required.
* This role also requires frequent unassisted lifting (not to exceed 50 lbs).
* Office-based work requires sitting.
* Repetitive use of arms/hands/wrists, especially when working with a computer.
* This position is based indoors and you will be primarily working with others, however, will also work independently and alone at times.
* Walking within and between buildings is required to enter laboratories and collaborate with others.
* This position is a team-based position that may require weekends, holidays, and off shift work.

SUPERVISORY RESPONSIBILITIES:

* This position requires providing direct supervision of individuals to provide coaching and mentorship to team members.