Biotech Process Engineer: Optimization & Troubleshooting

Inteldot; Puerto Rico; Hybrid; USD 60,000 - 80,000; Full time

Job summary

Inteldot is seeking an Administrative Shift professional to help characterize and optimize manufacturing processes. You will apply basic engineering principles to design and implement system modifications and analyze results for operational issues of moderate scope.

The role involves coordinating with manufacturing, utilities, quality assurance and validation teams, supporting deviations, equipment qualification, and process validation activities as needed.

Qualifications

• Educational background in Mechanical, Electrical and/or Chemical Engineering
• Statistical Analyses experience
• Experience in Biotech companies would be a plus
• Drug substance manufacturing/technical support would be a plus

Responsibilities

• 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.

Skills

Statistical analyses

Biotech experience

Drug substance manufacturing

Education

Master's degree in Engineering

Bachelor's degree in Engineering

Job description

Inteldot is seeking an Administrative Shift professional to help characterize and optimize manufacturing processes. You will apply basic engineering principles to design and implement system modifications and analyze results for operational issues of moderate scope.

The role involves coordinating with manufacturing, utilities, quality assurance and validation teams, supporting deviations, equipment qualification, and process validation activities as needed.