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.
WORK 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). Shift flexibility: Willing and able to support non-standard shifts, including nights, weekends, and extended hours.
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:- GMP knowledge: Strong background in regulated environments with ability to apply GMP in manufacturing and validation.
- Validation expertise: Experience in drafting, executing, and approving validation.
- Time pressure filling: Hands-on experience with time pressure filling systems.
- Technical documentation: Experience in preparing, reviewing, and approving protocols, reports, and strategy presentations.
- Protocol development: Experienced in designing protocols for complex systems such as filling lines and aseptic processes.
- Collaboration: Proven experience working with QA, Manufacturing, and Engineering teams during critical activities.
- 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.
- Communication skills: Strong written and verbal communication in English and Spanish.
- 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
