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:

1. Provide solutions to a variety of technical problems of moderate scope and complexity.
2. Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
3. Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
4. Initiate and complete routine technical tasks.

Operations Engineering:

1. Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems.
2. Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
3. Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.

Design Engineering:

1. Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
2. Work with consultants, architects and engineering firms on development of standard design documents.
3. Obtain and critique quotes for equipment modifications or installations.
4. Generate rudimentary project cost estimates and schedules.

* Other functions may be assigned*

Education:

• Master degree or Bachelor degree in Engineering  and 2 years of Engineering experience.
• Educational background in Mechanical, Electrical 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.

Preferred Qualifications:

• 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.

Work Methodology:

• 100% On-site 
• 7 months (1st Contract)
• Non- Standard shift operation including extended hours and weekends as per business needs. 
• Professional Service Contract