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:
Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects.
Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
Application of mature engineering knowledge in planning and conducting projects.
Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
Qualifications:
Bachelor's degree (Mechanical, Chemical) Engineering
5 years of Engineering experience
Experience Filling Characterization and Validations
Experience in New Product Introduction.
Ability to interpret and apply GLPs and GMPs.
In-depth knowledge of validation processes and requirements as applied to new equipment installations.
Working knowledge of pharmaceutical/biotech processes
Familiarity with documentation in a highly regulated environment
Ability to operate specialized laboratory equipment and computers as appropriate.
Availability for administrative 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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