Senior Engineering Manager
Raritan, NJ Posted: 2/11/2021
We are currently hiring a Senior Manufacturing Engineer on a long term contract to be based in the New Jersey area. This is a great opportunity to join a well established, global, business who are market leaders within their field. They are looking for an experienced Engineer who will be responsible for new and existing equipment for both Manufacturing & Facilities.
The Senior Manufacturing Engineer will develop and implement engineering solutions to that will drive and facilitate equipment improvements through the application of root cause failure analysis, primary owner/user of equipment history, and other processes. The role will also have full responsibility for managing capital and expense projects. This role is working for a Medical Device company so you must have knowledge of FDA and other regulatory guidance.
Below is a list of the key responsibilities for the role, whilst not exhaustive, that you"ll need to be able to perform;
- Design and selection of new production and facility systems, modifications and upgrades to existing equipment
- Preparation of capital estimates, generation of capital funding, control of project budgets, timely execution of new installations, equipment commissioning/validation, project scheduling and coordination
- Monitoring of equipment - including regular testing and ensuring maintenance tasks are carried out
- cGMP responsibilities will include owning and managing quality events related to process and facility equipment problems and corrective/preventive actions as well as adhering to the associated regulatory and change management actions related to projects
- NCs/ RCIs / CAPAs
To be successful in the role you"ll need to hold a Bachelor"s degree, BS preferred. Certificate in related field (CRM, PMP, etc. a plus) with 5 to 10 years" experience working in Manufacturing Engineering environment with Maintenance personnel and troubleshooting experience with advanced industrial equipment. Must have very strong communication and organizational skills. Knowledge and experience with Computerized Maintenance Management System (CMMS) a plus. Knowledge of FDA and other regulatory guidance is required.
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