Process Engineer

Infotree Global Solutions; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Infotree Global Solutions seeks an Operations Engineer to analyze processes, troubleshoot issues in manufacturing, pilot plant, or capital projects while applying basic engineering principles to design modifications and execute small-scale projects.

Preferred: a Bachelor’s in Engineering with ~2 years’ experience, familiarity with GLPs/GMPs, and ability to document results. Biotech purification and chromatography exposure is a plus.

Qualifications

• Bachelor’s degree in Engineering with ~2 years of engineering experience.
• Familiarity with GMP/GLP and regulated documentation.
• Ability to interpret validation protocols and apply basic engineering principles.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity.
• Evaluate and apply standard engineering techniques under supervision.
• Perform routine technical tasks with clear objectives.
• Collaborate with cross-functional teams for system modifications.

Skills

Problem solving

Verbal communication

Technical report writing

Analytical problem solving

Computer literacy

Education

Bachelor’s degree in Engineering

Job 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, analyses, and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.

FUNCTIONS

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

Operations Engineering:

1. 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.
2. Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
3. 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:

1. Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
2. Work with consultants, architects, and engineering firms on development of standard design documents.
3. Obtain and critique quotes for equipment modifications or installations.
4. Generate rudimentary project cost estimates and schedules.

* Other functions may be assigned.

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:

• o Problem solving and applied engineering.
• o Basic technical report writing.
• Verbal communication.
• Comprehensive understanding of validation protocol execution requirements.?

Demonstrated Skills in the following areas:

• o Basic technical presentations
• o Personal Organization
• o Validation Protocol Writing
• o Dealing with and managing change
• o Technical (Equipment Specific)
• o Analytical Problem Solving
• o Computer Literacy

Are there specific educational/software requirements needed?

Bachelor’s degree in Engineering & 2 years of Engineering experience

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

Experience in biotechnology processes, specifically in purification operations.

Knowledge in chromatography and UFDF techniques