Inteldot has over 14 years in the life science industry with allocations across Puerto Rico, United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
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. Administrative shift (8am-5pm).
Competencies / Skills:
- Writing technical documents, Filling, Process Validation, Mechanical or Chemical Engineering.
- Experience in technical reports, process investigations (including deviations, complaints, and CAPA), and inspection technology.
- 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.
- Validation Protocol Writing.
- In-depth knowledge of validation processes and requirements as applied to new equipment installations.
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 a broad variety of assignments in related fields.
- Serve 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 the development of standard design documents.
- Develop departmental budgets or project budgets encompassing multiple disciplines for the area within the project or the entirety of a smaller project.
Education:
- Master's degree and 3 years of Chemical or Mechanical Engineering experience, or bachelor's degree in Chemical or Mechanical Engineering and 5 years of Engineering experience.