Engineer

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

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.

Qualifications:

• Bachelor’s degree in Mechanical, Electrical and/or Chemical Engineering 
• Two (2) years of Manufacturing support experience
• Experience with equipment and/or process troubleshooting in a regulated environment.
• Knowledge of pharmaceutical/biotech processes and GMP production operations.
• Proficient presentation & communication skills in English and Spanish
• Validation Protocol Writing o Dealing with and managing change. 
• Corrective Action.
• Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.