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.

FUNCTIONS:

General:

1. Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
2. Develop engineering policies and procedures that affect multiple organizational units.
3. Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
4. Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
5. Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
6. Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
7. Application of mature engineering knowledge in planning and conducting projects.

*Other functions may be assigned*

EDUCATION:

• Doctorate or Masters + 2 years of Engineering experience.
• Bachelors in Engineering + 4 years of Engineering experience.
• Bachelor’s Degree in Engineering, preferred Mechanical, Electrical, or Chemical.

PREFERRED QUALIFICATIONS:

• Excellent written and verbal communication skills.
• Technical writing experience.
• Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, facilities, and equipment.
• Experience with change control, nonconformance, corrective and preventative actions, and validation practices.
• Experience with Maximo.
• Capable of working and/or submitting Purchase Orders (PO).
• Experience working and escorting vendors.
• Capable of handling multiple tasks, projects and/or priorities at the same time.
• Independent, self-motivated, organized, able to multi-task in project environments, and skilled in communication, facilitation, and collaboration.
• Work schedule flexibility as required to support 24/7 operations, requiring occasional after-hours engineering coverage.

SKILLS:

1. Working knowledge of pharmaceutical/biotech processes
2. Familiarity with validation processes
3. Familiarity with documentation in a highly regulated environment
4. Ability to operate specialized laboratory equipment and computers as appropriate.
5. Ability to interpret and apply GLPs and GMPs.
6. Ability to apply engineering science to production.
7. 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 presentationso Personal Organizationo Validation Protocol Writing
• Dealing with and managing changeo 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 development
• Facilitation
• Collaboration
• Basic project management
• 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

WORK METHODOLOGY:

• Full on site job in Juncos, PR
• Full time job
• Expected project duration: 6 months for the first contract, with a high possibility of extension based on performance and budget.
• Administrative shift. Weekends and overtime may also be required.
• Expected hiring date:  March 2026