Reliability Engineer - CMMS/Maximo

Infotree Global Solutions; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Infotree Global Solutions seeks an Operations/Design Engineer to support process optimization and troubleshooting in a GMP-regulated environment. The role applies basic engineering principles to system modifications, experiments, and projects of minor scope, with emphasis on data interpretation and reporting.

Requirements include a Bachelor’s in Engineering and at least 2 years of engineering experience; Master’s is a plus.

Qualifications

• Bachelor’s degree in Engineering with 2 years of Engineering experience.
• Master’s degree in Engineering or Bachelor’s degree with related experience in GMP environments.
• Experience in GMP-regulated pharmaceutical/biotech settings and technical report writing.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity.
• Evaluate and apply standard engineering techniques and procedures.
• Investigate variables and complete routine technical tasks.
• Collaborate with QA, validation, manufacturing and other teams as needed.

Skills

GMP experience

Technical report writing

Bilingual Spanish/English

Packaging equipment familiarity

Root cause investigations

CAPA management

DOE methods

Engineering problem-solving

Shift flexibility

Education

Bachelor’s degree in Engineering

Master’s degree in Engineering

Job description

Are there specific educational/software requirements needed?

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

Shift: 1st or 2nd

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

Experience working in a GMP-regulated environment within the pharmaceutical, medical device, or biotechnology industry

Proficiency in technical report writing

Effective communication skills in both Spanish and English (verbal and written)

Familiarity with packaging equipment, process characterization, validation, monitoring, and optimization techniques

Strong problem-solving skills and experience conducting root cause investigations

Expertise in identifying and managing Corrective and Preventive Actions (CAPAs)

Proficiency in statistical analysis and Design of Experiments (DOE) methodologies

Ability to apply engineering principles to solve technical issues in a production environment

Availability to support non-standard shifts, including extended hours, nights, weekends, and holidays

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, 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’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: 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