- 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 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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