Equipment Engineer

Responsibilities :

• Operational 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 - C / - C 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.
• Support the development, review and approval of calibration and maintenance plans in site CMMS system.
• Supports the execution of process improvement studies, as required.
• Adheres to written policies and procedures governing the Laboratory Systems Management department activities and the equipment they manage to ensure compliance with approved standards.
• Maintains a positive relationship with the site customers and outside vendors while promoting a positive team environment.
• 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.
• Inventory Management.
• 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 Client's 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 :

• Knowledge of cGMP, GXP, GAMP, SDLC regulations, including CFR part , computer systems validation requirements and good documentation practices.
• BS in Engineering or Science related discipline required.
• Minimum years of experience in FDA-regulated industry.
• Minimum 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.
• Occasional stooping, bending, stretching, pushing, pulling, reaching, and / or lifting up to lbs.
• Ability to sit, stand, walk, and move within workspace for extended periods.
• Ability to perform repetitive tasks, including hand to finger manipulations, grasping, pushing, and pulling.
30+ days ago