Senior Engineer - Process Optimization & Validation

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

Job summary

Biopharma-Consulting-Jad-Group is seeking a Senior Engineer to lead the characterization of process optimization strategies and troubleshoot operating issues across manufacturing, pilot plant, and capital project environments. The role uses advanced engineering to design major system modifications, experiments, and capital projects, and to present technical interpretations for complex initiatives.

The candidate will collaborate with Manufacturing, Process Development, Quality, Maintenance,

Qualifications

• Doctorate, or Master’s + 2 years engineering experience, or Bachelor’s + 4 years engineering experience.
• Preferred: Bachelor’s + 5 years engineering experience.

Responsibilities

• Lead complex or novel engineering assignments requiring new techniques and procedures.
• Plan, design, and execute projects of varying complexity.
• Serve as a specialist in at least one engineering technology area.
• Develop technical solutions to complex problems requiring ingenuity and judgment.
• Lead troubleshooting of operational issues in manufacturing, pilot plant, and facilities.
• Support deviations, CAPAs, change controls, risk assessments, and post‑inspection commitments.
• Collaborate with cross‑functional teams to develop requirements and recommendations for complex system modifications.
• Review and interpret engineering drawings, vendor docs, and performance data.
• Ensure compliance with cGMP, GLP, GDP, and regulatory expectations.

Skills

Pharma processes

Validation processes

GLPs/GMPs knowledge

Laboratory/manufacturing equipment

Analytical problem solving

Technical report writing

Presentations

Change management

Leadership/team-building

Financial analysis tools

Education

Doctorate in Engineering

Master’s degree + 2 years engineering

Bachelor’s degree in Engineering + 4 years

Bachelor’s degree + 5 years preferred

Tools

Excel

Validation software

QA/validation systems

ERP systems

Job description

Biopharma-Consulting-Jad-Group is seeking a Senior Engineer to lead the characterization of process optimization strategies and troubleshoot operating issues across manufacturing, pilot plant, and capital project environments. The role uses advanced engineering to design major system modifications, experiments, and capital projects, and to present technical interpretations for complex initiatives.

The candidate will collaborate with Manufacturing, Process Development, Quality, Maintenance,