Instrumentation Lifecycle Specialist

Category: Life Science

Employment Type: Contract

Reference: BH-363936

Instrumentation Lifecycle Sr. Specialist needed for a contract opportunity with Yoh Scientific's client based out of Syracuse, NY.

Pay Rate:$22-24/hour

Contract Length: One year

Schedule: 32 hours / Mon-Thurs 8am-5pm

Summary: The Instrument Lifecycle team provides operational and technical support to the QC laboratories by providing lifecycle support for QC analytical instrumentation and equipment. This enables the lab to operate efficiently and ensure capacity for incoming sample volumes. The QC Instrumentation Lifecycle Sr. Specialist is a member of Instrument Lifecycle team responsible for supporting the instrument/equipment program in the QC laboratories.

Key Responsibilities:

• Lead the major instrument related projects with functional areas to ensure all cGMP activities including qualification, validation and engineering activities are performed in accordance with the site analytical master plan.
• Initiate and complete instrument related change controls, including execution of pre and post implementation requirements.
• Author documentation for instrument qualification and computer software/hardware validation protocols and final reports in conjunction with department subject matter experts and quality assurance.
• Performs the execution of qualification/validation activities for commissioning of new instrumentation.
• Executes performance verifications to ensure instrument performance.
• Author and approve periodic reviews of computer system validation and instrument qualifications.
• Maintain comprehensive inventory of instrument and equipment with the laboratory and status.
• Maintain instruments in the Computerized Maintenance Management System (CMMS), including creation of service requests, and submission of work orders for repair.
• Lead the QC calibration program by monitoring calibration schedules, scheduling calibrations and responding to calibration alerts.
• Schedule vendors for service, maintenance, or other issues. Execution of troubleshooting activities with laboratory partners is required.
• Lead calibration failure investigations including performance of instrument deficiencies to support timely return to service.
• Interact with inspectors/auditors during internal and external audits.
• Maintain the process to store laboratory instrumentation within the Laboratory Execution System (LES) and other laboratory systems.
• Collaborate with site function teams to ensure that all data integrity requirements are being met within the laboratory.
• Lead and or present information at departmental or staff meetings .

• Working knowledge of laboratory systems much as Empower, NuGenesis and other software programs, including Microsoft Office Applications, preferred.
• Knowledge base of regulatory requirements for cGMP, computerized analytical systems, i.e. 21 CFR part 11, cGMP, data integrity, instrument life cycle, validation, disaster recovery and retirement preferred. Demonstrated problem solving ability, attention to detail, and analytical thinking skills.
• Interpersonal, oral and written communication skills are essential.
• Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility.
• Ability to work independently with minimal supervision.
• Contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.
• Demonstrate leadership ability to lead projects with minimal supervision.

• Minimum of BS in relevant scientific or computer area with 3-6 years' experience in the biopharmaceutical industry or equivalent combination of education and experience.

• Medical, Dental & Vision Benefits
• 401K Retirement Saving Plan
• Life & Disability Insurance
• Direct Deposit & weekly ePayroll
• Employee Discount Programs
• Referral Bonus Programs