Description:

Summary

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, analyses, 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

• Master’s degree or bachelor’s degree in engineering & 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 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.

What attributes (i.e. - preferred qualifications) would make this candidate stand out?              

• Experience in data analysis.
• Optional knowledge of aseptic operation (filling and support).
• Recommended experience in engineering reliability elements and process excellence.
• Recommended experience in maintenance systems and asset management