Engineer (Process Validation)- 33938

Juncos, Puerto Rico

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:

Master degree OR Bachelor degree in Engineering & 2 years of Engineering experience (Mechanical Engineering or Chemical Engineering)

Preferred Qualifications:

GMP experience, some knowledge in validation activities, preferable process validation. Must be fluent in English
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) o
- Analytical Problem Solving o
- Computer Literacy

Work Methodology: