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 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
- Develop engineering policies and procedures that affect multiple organizational units.
- Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
- Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
- Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
- 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.
Qualifications:
- Bachelor Degree in Mechanical, Industrial, Chemical or Electrical Engineering
- Five (5) years of Previous experience in Engineering
- Knowledge in URS, DS, and Equipment Risk Assessments
- Characterization and Validation experience
- Development of Characterization and Validation protocols
- Execution of Characterization and Validation protocols
- Develop Characterization and Validation reports
- Device assembly equipment and packaging equipment validation experience
- Availability for 1st shift
- First shift but it could be second or third during some executions
Top Skills
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools.
Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
