Equipment Engineer - Katalyst Healthcares & Life Sciences
Warren, NJ 07059
About the Job
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 -20 C / -80 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.
- Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
- 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.
- Occasional stooping, bending, stretching, pushing, pulling, reaching, and/or lifting up to 25 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.
Source : Katalyst Healthcares & Life Sciences
