The Role
Provide engineering support for GMP-regulated manufacturing: troubleshoot equipment and processes, supervise production performance, support deviations, equipment qualification, process validation, cross-functional improvements, documentation, and new product introductions while working non-standard shifts.
Summary Generated by Built In
We are seeking an Engineer with experience in regulated industry 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.
- 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
- Masters or Bachelor’s in Engineering + 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
- Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.
Skills Required
- Master's or Bachelor's in Engineering plus 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 and technical writing skills
- Proficient presentation and communication skills in English and Spanish
- Ability to support 24/7 non-standard shift operations including extended hours and weekends
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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.
