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Equipment Engineer - Trenton, United States - System One
Description
Job Title :
Equipment Engineer
Location :
Warren, NJ
Hours/Schedule :
Monday - Friday; 1st Shift
Type:
Contract
Job Description
The LSM Equipment Engineer supports the successful operation of laboratory and clinical manufacturing operations at their home sites through interaction with internal team members and internal customers, and external service providers.
The incumbent conducts tasks assigned by the management independently or with minimum supervision.The LSM Equipment Engineer is responsible for initiating and owning deviations, CAPAs, and change controls, and authoring calibration and maintenance SOPs as well as performing calibrations, maintenance, and qualifications/validations.
ResponsibilitiesOperational Activities
Executes equipment calibration, preventative maintenance, performance verification and repair activities in laboratory and manufacturing areas.
Supervises vendors for calibration, preventative maintenance, performance verification and repair functions.
Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, and completeness.
Ensures all calibration, PM, and performance verification records are filed appropriately after approval.
Executes requalification on Controlled Temperature Units (ex. Refrigerators, Freezers (which includes -20C / -80C Freezers), Incubators, Cryotanks, and Cryopods).
Supports multiple sites within Warren and Summit.
Owns and supports deviations and investigations that result from calibration or performance verification activities, along with developing and supporting the implementation of corrective and preventive actions.
Authors and supports the development, revision, and review of written procedures for calibration, preventive maintenance, and performance verification of equipment.
Supports the execution of process improvement studies, as required.
Adheres to written policies and procedures governing the LSM department activities and the equipment they manage to ensure compliance with approved standards.
Follows cGMP (current Good Manufacturing Practices) and ALCOA principles ('ALCOA' defines that data should be Attributable, Legible, Contemporaneous, Original, and Accurate) In addition, 'ALCOA+' guidance recommends that data is also Complete, Consistent, Enduring, and Available.
Work with Planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed.
Approves Change Request, Asset Inductions, and Work Request.
Approving Calibration and Maintenance forms.
Perform NCRs investigations.
Review and approve calibration and maintenance work.
Regulatory Responsibilities
Maintains all required Corporate, Facilities and EHS training as required.
Adheres to all safety procedures and hazard communication.
May be called upon to act as SME in both internal and regulatory audits.
Requirements
BS in Engineering or Science related discipline required
Minimum 3 years of experience in FDA-regulated industry.
Minimum 3 years of experience working directly with laboratory equipment (ex. centrifuges, temperature/humidity meters, balances, freezers, refrigerators etc.)
Maintenance coordination / planning experience preferred.
Experience working in a clinical environment preferred.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
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