Are there specific educational/software requirements needed?
Master’s degree OR
Bachelor’s degree in Engineering & 2 years of Engineering experience
What attributes (i.e. - preferred qualifications) would make this candidate stand out?
Experience in biotechnology processes, specifically in purification operations.
Knowledge in chromatography and UFDF techniques
Summary
- Under general supervision, provides characterization of:
- Process optimization strategies.
- Troubleshooting of operational issues in operations, manufacturing, pilot plant, or capital projects environments.
- Applies basic engineering principles to:
- Design and implementation of system modifications.
- Experiments.
- Capital projects.
- Organizes, analyzes, and presents interpretation of results for:
- Operational issues.
- Engineering projects of minor scope and complexity.
FunctionsGeneral Engineering
- Provide solutions to a variety of technical problems of moderate scope and complexity.
- Under general supervision, evaluate, select, and apply standard engineering techniques and procedures; assistance is provided for unusual problems.
- Perform assignments with clear and specific objectives requiring investigation of a limited number of variables.
- Initiate and complete routine technical tasks.
Operations Engineering
- Function as a technical expert for equipment or systems related to operational troubleshooting.
- Become actively involved in daily operations when required to meet schedules or resolve complex problems.
- Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
- Collaborate with:
- Research
- Manufacturing
- Maintenance
- Process Development
- Utilities
- Facilities
- Quality Assurance
- Validation
- Develop requirements and recommendations for system modifications.
Design Engineering
- Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
- Collaborate with consultants, architects, and engineering firms on the development of standard design documents.
- Obtain and critique quotes for equipment modifications or installations.
- Generate basic project cost estimates and schedules.
- Perform other functions as assigned.
Education
- Master's degree OR
- Bachelor's degree in Engineering with 2+ years of engineering experience.
Preferred Qualifications
- 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 principles/science to production.
- Ability to develop solutions to routine technical problems of limited scope.
- Demonstrated skills in:
- Problem solving and applied engineering.
- Basic technical report writing.
- Verbal communication.
- Basic technical presentations.
- Personal organization.
- Validation protocol writing.
- Dealing with and managing change.
- Technical/equipment-specific knowledge.
- Analytical problem solving.
- Computer literacy.
- Comprehensive understanding of validation protocol execution requirements.
Pay: $30.00 - $34.00 per hour
Benefits:
Application Question(s):
- Knowledge in chromatography and UFDF techniques
Work Location: In person
