The Role
Provides engineering support for daily manufacturing operations through troubleshooting, process optimization, equipment and system modifications, upgrades, and replacements. Collaborates with manufacturing, maintenance, quality, validation, utilities, and facilities teams. Supports deviations, equipment qualification, process validation, procedures, training, new product introductions, experiments, and capital projects. Monitors operational performance, recommends solutions, and provides technical mentorship. Requires support for 24/7 non-standard shifts, including extended hours and weekends.
Summary Generated by Built In
We are seeking an Engineer to 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.
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.
Requirements
- Master’s degree or Bachelor’s degree in Engineering & 2 years of Engineering experience
- Fully Bilingual (English & Spanish)
Skills Required
- Bachelor's or Master's degree in Engineering
- Two years of engineering experience
- Fully bilingual in English and Spanish
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The Company
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.
