We are seeking an Engineer that will 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.

The professional must 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.

Specific responsibilities include but are not limited to:

• 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.

Requirements

Bachelor’s or Master’s degree in Mechanical, Electrical, or Chemical Engineering.
Minimum of 2 years of engineering experience.
Experience troubleshooting equipment and/or manufacturing processes within a regulated environment.
Working knowledge of pharmaceutical or biotechnology manufacturing processes and GMP operations.
Strong organizational, technical writing, and documentation skills.
Excellent verbal, written, presentation, and communication skills in both English and Spanish.
Ability to effectively communicate technical information and collaborate across multidisciplinary teams.

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