Senior Process Engineer - GMP/Qualification Leader

Frey Consulting Group; Juncos (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Frey Consulting Group is seeking a Senior Engineer to independently lead process characterization, optimization, and troubleshooting within operations, manufacturing, pilot plants, and capital projects. The role emphasizes applying advanced engineering principles to design and implement major system modifications and to present technical results to stakeholders.

The candidate will collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and

Qualifications

• Master's degree in Engineering with 2+ years of engineering experience.
• Bachelor's degree in Engineering with 4+ years of engineering experience.

Responsibilities

• Develop and implement commissioning and qualification strategies that align with project objectives.
• Supervise engineers, associates, and technicians on ongoing and project-based assignments.
• Coordinate with cross-functional teams and vendors to ensure design, qualification, and documentation completeness.
• Apply advanced engineering methods to plan, execute, and manage complex system modifications.
• Develop technical solutions and recommendations from characterization data.
• Support risk assessment, change control, and CAPA activities across validated systems.

Skills

Process characterization

Troubleshooting

Project leadership

Cross-functional collaboration

Education

Master's degree in Engineering + 2 years experience

Bachelor's degree in Engineering + 4 years experience

Job description

Frey Consulting Group is seeking a Senior Engineer to independently lead process characterization, optimization, and troubleshooting within operations, manufacturing, pilot plants, and capital projects. The role emphasizes applying advanced engineering principles to design and implement major system modifications and to present technical results to stakeholders.

The candidate will collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and