"Alerted.org

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:

+ Provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.

+ Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.

+ Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.

+ 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 Engineering

+ 2 years of relevant experience

+ Experience in the purification process of protein is preferred.

+ Experience working with investigations, troubleshooting, process improvements, technical writing.

+ Familiarity with validation processes

+ Comprehensive understanding of validation protocol execution requirements.

+ Able to develop solutions to routine technical problems of limited scope

+ Knowledge of pharmaceutical/biotech processes and GMP production operations

+ Organizational & technical writing skills

+ Administrative Shift (8-hour shift)

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity,, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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