Analysis Skills, Assembly Equipment, Biology, Biotech and Pharmaceutical, Budget Management, Budgeting, Capital Project, Design Document, Documentation, Documentation Standards, Engineering, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), Identify Issues, Manufacturing, Manufacturing/Industrial Processes, Pilot Plant, Policy Development, Procedure Development, Process Development, Process Improvement, Project Schedule, Quality Assurance, Requirements Management, Software Engineering, Standards Development, Technical/Engineering Design
Inteldot has over 15 years in the life science industry with allocations across Puerto Rico, the United Sates, Europe and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Administrative Shift
Job Description:
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.
Requirements:
- Experience in parenteral products, vision system, device assembly and packaging.
- Working knowledge of pharmaceutical/biotech processes
- Familiarity with validation processes
- Familiarity with documentation in a highly regulated environment
- Ability to operate specialized laboratory equipment and computers as appropriate.
- Ability to interpret and apply GLPs and GMPs
- Ability to apply engineering science to production.
- Able to develop solutions to routine technical problems of limited scope
Responsibilities:
- Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
- 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.
- Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
- 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.
- Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
- Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
- Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project
Education:
- Doctorate OR Masters + 2 years of Engineering experience OR Bachelor's in engineering + 4 years of Engineering experience.