Senior Process Engineer: Pharma Process Optimization Lead

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 90,000 - 150,000; Part time

Job summary

BioPharma Consulting JAD Group is seeking a Senior Engineer to independently lead process optimization, troubleshooting, and capital project activities across operations and engineering environments. The role applies advanced engineering principles to design and implement major system changes, experiments, and process improvements.

Responsibilities include developing validation-ready documentation, supporting regulatory inspections, and coordinating cross-functional activities with

Qualifications

• Pharma/biotech process knowledge required.
• Experience with validation protocols and GMP/GLP/GDP.
• Extensive documentation in regulated environments.

Responsibilities

• Lead complex process optimization, troubleshooting, and capital projects.
• Develop and implement design documentation and standard change controls.
• Coordinate with multiple functions to define requirements for major system modifications.
• Support regulatory inspections with investigations and CAPA.
• Manage project budgets and external vendors to meet schedule and quality goals.

Skills

Pharma processes

Validation

Documentation

GMP/GLP/GDP

Engineering analysis

Project management

Root cause analysis

Budgeting

Team leadership

Vendor management

Cross-functional collaboration

Education

Doctorate in Engineering

Master’s + 2 years engineering

Bachelor’s in Engineering + 4 years

Tools

TrackWise

Spotfire

CDOCS

Job description

BioPharma Consulting JAD Group is seeking a Senior Engineer to independently lead process optimization, troubleshooting, and capital project activities across operations and engineering environments. The role applies advanced engineering principles to design and implement major system changes, experiments, and process improvements.

Responsibilities include developing validation-ready documentation, supporting regulatory inspections, and coordinating cross-functional activities with