Inteldot has over 14 years in the life sciences industry with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
SHIFT: This position requires during execution availability on first, second and third shifts. The majority of the time will be administrative shift (8am to 5pm)
Description:Independently provides and/or directs the characterization of process optimization strategies and 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, processes, and/or capital projects. Develops, organizes, analyzes, and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
Principal Requirements:- Technical Report writing
- Design of experiment
- Aseptic Manufacturing (Filling)
- Process Validation
- Working knowledge of pharmaceutical/biotech processes.
- Familiarity with validation processes and 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.
- In-depth knowledge of validation processes and requirements for new equipment installations.
- Specialized equipment/process expertise.
- Expertise in schedule development, facilitation, and collaboration.
- Strong problem-solving skills, requiring the application of scientific and engineering theory.
- Ability to delegate and manage project work efficiently.
- Demonstrated skills in:
- Technical report writing and validation protocol writing.
- Basic technical presentations and project management.
- Leadership, team building, and conflict resolution.
- Negotiation, persuasion, and facilitation.
- General Engineering:
- Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
- Develop engineering policies and procedures impacting multiple organizational units.
- Employ advanced engineering techniques within the area of expertise and across related fields.
- Apply mature engineering knowledge in planning and conducting projects.
- Serve as a peer-recognized engineering technology specialist in at least one area, determining methodologies and best practices.
- Design Engineering:
- Develop technical solutions to complex problems requiring ingenuity and creativity.
- Work with research, manufacturing, process development, utilities, facilities, quality assurance, and validation departments to develop requirements for large and complex system/facility modifications.
- Collaborate with project managers to complete design and engineering projects within schedule, budget, and quality constraints.
- Coordinate with consultants, architects, and engineering firms for the development of standard design documents.
- Bachelor’s degree and 4 years of Engineering experience
- Preferably Mechanical and Chemical Engineering
Top Skills
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing.
We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
