MC
Engineer - 35786
Mirus Consulting Group
- 🇵🇷 Puerto Rico
- 1 day ago
- Regulatory Compliance
- GMP
- Technical Writing
1 day ago
Position Summary
We are seeking a highly motivated Engineer to provide technical engineering support to manufacturing operations within a regulated pharmaceutical/biotechnology environment. The successful candidate will support continuous daily operations through troubleshooting activities, process optimization initiatives, equipment upgrades, replacements, and process modifications. This role requires collaboration across multiple functional areas to ensure operational excellence, regulatory compliance, and uninterrupted manufacturing performance.
The Engineer will serve as a technical resource for manufacturing processes, equipment, and systems while supporting quality and operational objectives in accordance with GMP requirements, corporate policies, and applicable regulatory standards.
Key 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.
Qualifications
- Master's Degree in Engineering OR
- Bachelor's Degree in Engineering with a minimum of 2 years of engineering experience
- Educational background in: Mechanical Engineering, Electrical Engineering, Chemical Engineering.
- Experience troubleshooting equipment and/or manufacturing processes in a regulated environment.
- Knowledge of pharmaceutical and/or biotechnology manufacturing processes.
- Familiarity with GMP regulations and production operations.
- Strong technical writing, organizational, and documentation skills.
- Effective verbal and written communication skills in both English and Spanish.
- Ability to support non-standard shifts, including nights, weekends, and extended hours as required.
 This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.
Engineer - 35786 · Mirus Consulting Group