Description:

• Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.

Functions:

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
• Perform assignments that have clear and specific objectives and require investigation of limited number of variables. (*)
• Initiate and complete routine technical tasks.

Operations Engineering:

• Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems. (*)
• Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity. (*)
• Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing 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. (*)
• Work with consultants, architects and engineering firms on development of standard design documents. (*)
• Obtain and critique quotes for equipment modifications or installations.
• Generate rudimentary project cost estimates and schedules.

* Other functions may be assigned

Education:

• Masters Degree
• Bachelor's degree in Engineering & 2 years of Engineering experience 

Preferred qualifications:

• Candidate should have experience providing support to manufacturing activities, preferably knowledge in chromatography and filtration systems.
• Knowledge in PI historian, statistical analysis and protein purification techniques are recommended.
• 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 o Validation Protocol Writing
  • Dealing with and managing change
  • Technical (Equipment Specific)
  • Analytical Problem Solving
  • Computer Literacy

Work Methodology: 

• 100% on Site
• 9 months (1st Contract) 
• 8 hrs. (Administrative Shifts) 
• Professional Services Contract