Senior Process Engineer - GMP/Pharma Optimization

Frey Consulting Group; Juncos (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

Frey Consulting Group is seeking a Senior Engineer to independently characterize, optimize processes, and troubleshoot operations within manufacturing, pilot plants, or capital projects. You will design and implement major system modifications, run validations, and present results to cross-functional teams.

Ideal candidates hold advanced engineering degrees with extensive experience in regulated environments, GMP/GLP, protocol writing, and project management, and demonstrated ability to lead

Qualifications

• Doctorate in Engineering or MS with 2+ years of experience.
• BS in Engineering with 4+ years of experience.
• Experience with validation processes and regulatory documentation (GMP/GLP).
• Knowledge of pharmaceutical/biotech production environments.

Responsibilities

• Lead complex process optimization and troubleshooting efforts.
• Develop, validate, and implement major system modifications and capital projects.
• Prepare technical reports, validation docs, and engineering-related material.
• Coordinate diverse stakeholders and manage multiple projects to completion.

Skills

Process optimization

Troubleshooting

GMP/GLP

Project management

Technical reporting

Cross-functional collaboration

Communication skills

Contractor coordination

Change management

Analytical problem solving

Team leadership

Education

PhD in Engineering

MS in Engineering (2+ yrs exp)

BS in Engineering (4+ yrs exp)

Job description

Frey Consulting Group is seeking a Senior Engineer to independently characterize, optimize processes, and troubleshoot operations within manufacturing, pilot plants, or capital projects. You will design and implement major system modifications, run validations, and present results to cross-functional teams.

Ideal candidates hold advanced engineering degrees with extensive experience in regulated environments, GMP/GLP, protocol writing, and project management, and demonstrated ability to lead