EDUCATION REQUIREMENTS
-Doctorate OR
-Masters + 2 years of Engineering experience OR
-Bachelors in Engineering + 4 years of Engineering experience.
PREFERRED QUALIFICATIONS
o Experience in Pharmaceutical or biotechnology industry equipment Commissioning and qualification, installation qualifications.
o Experience in CIP and SIP cycle development.
o Experience developing project plans and strategies.
o Organized, multitasking and ability to work on high pace environment.
o Maximo
SUMMARY
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.
COMPETENCIES/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.
- Ability to interpret and apply GLPs and GMPs.
- Ability to apply engineering science to production.
- Able to develop solutions to routine technical problems of limited scope
Demonstrated skills in the following areas:
-Problem solving and applied engineering.
-Basic technical report writing
-Verbal communication
-Comprehensive understanding of validation protocol execution requirements.
Demonstrated Skills in the following areas:
-Basic technical presentations, Personal Organization, Validation Protocol Writing
-Dealing with and managing change, Technical (Equipment Specific)
-Analytical Problem Solvingo Computer Literacy
-Specialized equipment/process expertise
-In-depth knowledge of validation processes and requirements as applied to new equipment installations
-Interacts effectively with variety of communication and working styles
-Ability to independently determine when additional internal resources are required to solve problems
-Ability to handle multiple projects at one time
Demonstrated Skills in the following areas:
-Schedule developmento Facilitation
-Collaboration
-Basic project managemento Completion and follow-up
-Established expertise in at least 3 separate areas of engineering technology.
-Ability to independently determine when additional external resources are required to solve problems
-Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
-Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach
-Working knowledge of financial analysis tools
-Ability to delegate and manage the project work of others
Demonstrated Skills in the following areas:
-Negotiation, persuasion and facilitation
-Collaboration
-Project cost development
-Conflict Resolution
-Leadership and teambuilding
-Management of contractors and vendors
Job Types: Full-time, Contract
Pay: $47.00 - $50.00 per hour
Expected hours: 40 per week
Work Location: In perso
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