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 derate 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: 

• Master’s degree
• Bachelor’s degree in Engineering & 2 years of Engineering experience.
• Preferred background: Chemical Engineering

Preferred Qualifications:

• Experience in Biotech companies would be a plus
• Statistical Analyses experience
• Drug substance manufacturing/technical support
• 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 Solving
  • Computer Literacy

Work Methodology:

• 100% On-site 
• 2 years (1st Contract)
• 1st & Administrative Shift: (6am -2:30pm &8am-5pm)
• Professional Service Contract