Engineer-PRQN737

Frey Consulting Group; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Frey Consulting Group seeks an Engineer to support process characterization, optimization, and troubleshooting in operations, manufacturing, pilot plant, or capital projects. You will design and implement system modifications and present results from projects of limited scope and complexity.

Responsibilities include troubleshooting production equipment, validating processes, applying GLP/GMP requirements, and collaborating with multiple departments to drive compliant improvements.

Qualifications

• Experience in GMP-regulated environments preferred.
• Knowledge of validation processes and documentation.
• Ability to apply GLP and GMP requirements to engineering tasks.
• Experience conducting root cause investigations.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity.
• Evaluate and apply standard engineering techniques under supervision.
• Perform assignments with defined objectives and limited variables.
• Initiate and complete routine technical tasks.
• Apply engineering principles to production-related issues.
• Support process characterization, optimization, monitoring, and troubleshooting.
• Collaborate with cross-functional teams to develop system modification requirements.
• Prepare basic project cost estimates and schedules.
• Support design, engineering, and construction projects within schedule and budget constraints.
• Obtain and evaluate quotations for equipment modifications or installations.

Skills

GMP regulatory understanding

Validation knowledge

DOE & statistics

Root cause investigations

Education

Bachelor’s degree in Engineering with at least 2 years of engineering experience

Job description

Shift Requirements: 1st or 2nd Shift; must be available to work different shifts and/or weekends based on business needs

Position Available: 1

Contract Duration: 6 months

This opportunity is available exclusively to direct individual candidates. Third-party contractors, staffing agencies, vendors, and Corp-to-Corp (C2C) arrangements will not be considered.

Position Summary

Under general supervision, the Engineer provides support for process characterization, optimization strategies, and troubleshooting of operational issues within operations, manufacturing, pilot plant, or capital project environments.

The Engineer applies fundamental engineering principles to the design and implementation of system modifications, experiments, and capital projects. This role also organizes, analyzes, and presents results related to operational issues and engineering projects of limited scope and complexity.

Key Responsibilities

Engineering & Technical Support

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Evaluate, select, and apply standard engineering techniques and procedures under general supervision.
• Perform assignments with clear and specific objectives that require investigation of a limited number of variables.
• Initiate and complete routine technical tasks.
• Apply engineering principles to solve technical issues in a production environment.
• Develop solutions to routine technical problems of limited scope.
• Support process characterization, optimization, monitoring, and troubleshooting activities.

Operations Engineering

• Serve as a technical resource for equipment and systems, including operational troubleshooting.
• Become actively involved in daily operations when required to meet schedules or resolve complex problems.
• Routinely audit the operational performance and regulatory compliance of equipment and systems of moderate quantity and significant complexity.
• Collaborate with Research, Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams to develop requirements and recommendations for system modifications.
• Apply engineering science and technical knowledge to support production operations.
• Support packaging equipment-related activities, including process characterization, validation, monitoring, and optimization.
• Work under the direction of project managers to support design, engineering, and construction projects within established schedule and budget constraints.
• Collaborate with consultants, architects, and engineering firms in the development of standard design documents.
• Obtain and evaluate quotations for equipment modifications or installations.
• Prepare basic project cost estimates and schedules.
• Support engineering modifications, experiments, and capital projects as assigned.

Validation, Quality & Compliance

• Support validation activities and understand validation protocol execution requirements.
• Prepare and/or contribute to validation protocols and technical documentation.
• Work effectively within a highly regulated environment.
• Apply applicable GLP and GMP requirements to engineering and production activities.
• Conduct root cause investigations and support the identification and management of Corrective and Preventive Actions (CAPAs).
• Apply statistical analysis and Design of Experiments (DOE) methodologies as appropriate.

Communication & Documentation

• Organize, analyze, and present technical results and recommendations.
• Prepare basic technical reports and presentations.
• Communicate effectively with cross-functional teams in both Spanish and English, verbally and in writing.
• Maintain strong personal organization and adapt effectively to changing priorities and requirements.
• Additional responsibilities may be assigned based on business needs.

Required Education

• Bachelor’s degree in Engineering with at least 2 years of engineering experience.

Preferred Qualifications & Experience

• Experience working in a GMP-regulated environment within the pharmaceutical, medical device, or biotechnology industry.
• Working knowledge of pharmaceutical and/or biotechnology processes.
• Familiarity with validation processes and documentation within a highly regulated environment.
• Familiarity with packaging equipment, process characterization, validation, monitoring, and optimization techniques.
• Ability to interpret and apply GLP and GMP requirements.
• Ability to apply engineering principles to production-related technical issues.
• Strong problem-solving and analytical skills.
• Experience conducting root cause investigations.