Senior Engineer – On-site GMP/Process Lead (Puerto Rico)

ProQuality Network; Juncos (PR); On-site; USD 90,000 - 140,000; Full time

Job summary

ProQuality Network in Juncos, Puerto Rico, seeks a Senior Engineer to independently lead process characterization, optimization, and troubleshooting across operations, manufacturing, and capital projects.

The role emphasizes advanced engineering design, C&Q planning, and cross-functional collaboration with quality, validation, and manufacturing teams. Strong leadership and regulatory knowledge are essential.

Qualifications

• Advanced engineering principles applied to major system modifications.
• Experience leading cross-functional teams in operations, manufacturing, and capital projects.
• Knowledge of GMP, FDA requirements and validation concepts.
• Ability to organize, analyze, and present technical results and recommendations.

Responsibilities

• Complete complex or novel assignments requiring new engineering techniques and solutions.
• Develop engineering policies and procedures impacting multiple units.
• Supervise and review work of engineers and technicians on projects.
• Coordinate with project managers to meet schedule, budget, and quality targets.
• Oversee commissioning activities including FAT/SAT and field testing.
• Collaborate with cross-functional teams to define requirements for large-scale modifications.

Skills

Process characterization

Troubleshooting

Project leadership

Engineering design

Cross-functional collaboration

Validation

GMP/FDA knowledge

Education

Doctorate degree

Master's degree + 2 years

Bachelor's degree + 4 years

Job description

ProQuality Network in Juncos, Puerto Rico, seeks a Senior Engineer to independently lead process characterization, optimization, and troubleshooting across operations, manufacturing, and capital projects.

The role emphasizes advanced engineering design, C&Q planning, and cross-functional collaboration with quality, validation, and manufacturing teams. Strong leadership and regulatory knowledge are essential.