SUMMARY
Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity
FUNCTIONS
- Provide solutions to a variety of technical problems of moderate scope and complexity.
- Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
- Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
- Initiate and complete routine technical tasks. Operations Engineering
REQUIREMENTS
- Master degree OR Bachelor degree in Engineering & 2 years of Engineering experience
- Educational background in Mechanical, Electrical, Industrial and/or Chemical Engineering
- Experience with equipment and/or process troubleshooting in a regulated environment.
- Knowledge of pharmaceutical/biotech processes and GMP production operations.
- Organizational & technical writing skills.
- Proficient presentation & communication skills in English and Spanish
- Provide technical engineering support to continuous daily operations by performing troubleshooting activities, process optimization strategies,upgrades, replacements, and modifications to the process or equipment in the manufacturing operations.
- Ensure that all operations are accomplished in a compliant manner consistent with current corporate policies, industry standards, and applicable regulatory requirements.
- This role will support non-standard shift manufacturing operations that may nights and weekends.
- Provide solutions to a variety of technical problems of moderate scope and complexity.
- Under general supervision will evaluate, select and apply standard engineering techniques, basic principles and procedures. Assistance given for unusual problems.
- Function as a technical expert to process, equipment and/or systems during troubleshooting operations and multi-functional discussions.
- Frequently become actively involved in daily operations when required to meet schedules or to resolve sophisticated problems.
- Routinely supervise manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship.
- Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for process and/or system modifications.
- Support the execution of manufacturing/quality systems such as deviations, equipment qualification and/or process validation, procedures, training, and new product introductions.
- Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
- Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of moderate scope and complexity.
- Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.
Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.
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- Shift: 2/3/2 1st shift 5am to 5:30pm
