We are seeking an Engineer who 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.
Ensure that all operations are accomplished in a compliant manner consistent with current corporate policies, industry standards, and applicable regulatory requirements. The responsibilities are the following:
- Provide solutions to a variety of technical problems of moderate scope and complexity. Under general supervision, evaluate, select, and apply standard engineering techniques, basic principles, and procedures. Assistance is 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.
- Organize, analyze, and present 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 24/7 non-standard shift operations, including extended hours and weekends, as required by business needs.
Requirements
- Master’s Degree or Bachelor’s Degree in Engineering and 2 years of engineering experience (Areas of: Mechanical, Electrical, Industrial or Chemical Engineering).
- Experience with equipment and/or process troubleshooting in a regulated environment.
- Knowledge of pharmaceutical/biotech processes and GMP production operations.
- Organizational and technical writing skills.
- Proficient presentation and communication skills in both English and Spanish.
Skills Required
- Master's Degree or Bachelor's Degree in Engineering
- 2 years of engineering experience in Mechanical, Electrical, Industrial or Chemical Engineering
- Experience with equipment and/or process troubleshooting in a regulated environment
- Knowledge of pharmaceutical/biotech processes and GMP production operations
- Organizational and technical writing skills
- Proficient presentation and communication skills in both English and Spanish
What We Do
QRC Group specializes in providing expert consulting services in regulatory compliance, quality management, and risk management for the pharmaceuticals, medical devices, biotechnology, and other regulated industries, delivering comprehensive project management and validation solutions.
