DESCRIPTION
Independently provides and/or directs the characterization of process optimization strategies. 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
EDUCATION
Master’s degree and 3 years of Engineering experience or bachelor’s degree in Engineering and 5 years of Engineering experience
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.
- 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.
- 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.
- Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.
- Support Capital Projects engineering activities:
- Pre-construction Phase
- Non-Invasive Construction Phase
- Construction Phase / Commissioning
REQUIREMENTS/SKILLS
- 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.
- Basic technical report writing.
- Comprehensive understanding of validation protocol execution requirements.
- Ability to write technical documents, develop and execute detailed protocols.
- Project Management Skills.
- Maximo and Trackwise Knowledge is a plus.
- Problem solving and applied engineering.
- Good verbal and writing communication (Bilingual)
Ultimate Solutions Corp is an Equal Opportunity Employer.