GMP Process Engineer — 6-Month Contract

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

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.