Inteldot has over 14 years in the life science industry with allocations a cross Puerto Rico, United Sates, Europe and Japan. This is a great opportunity for one of our leading clients Segoe UI in Puerto Rico.
Description:
Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Administrative Shift.
Responsibilities:
- Able to troubleshoot systemic validation issues.
- Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects.
- Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity.
- Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures.
- Develop validation engineering policies and procedures that affect multiple organizational units.
- Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis.
- Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise.
- Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields.
- Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
- Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex processes, system/facility modifications.
- Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints.
- Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
Competencies / Skills:
- Advanced validation knowledge (equipment qualification, cleaning, sterilization).
- Experience working with Analytical Instruments
Education:
- Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience