Bioprocess Investigations & Process Improvement Specialist

Mentor Technical Group; Juncos (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

Mentor Technical Group seeks a process-focused engineer to support biologics manufacturing operations in a regulated environment. The role emphasizes investigations, GDP-compliant documentation, and collaboration across Manufacturing, Process Development, Quality, and Engineering to ensure compliance and product quality.

You will monitor processes, perform root cause analyses, and contribute to Lean initiatives, presenting technical findings and recommendations.

Qualifications

• Bachelor's degree in engineering, biotechnology, life sciences, or related field.
• Experience in regulated pharmaceutical/biotech/medical device manufacturing.
• Strong English and Spanish written and verbal communication.
• Proficiency in technical writing and presentation development.
• Ability to work in a team-based environment.
• Ability to work independently with minimal supervision.
• Willingness to work extended hours when required.

Responsibilities

• Support manufacturing operations and bio-processing activities.
• Conduct investigations, deviations, and root cause analyses.
• Monitor processes and identify continuous improvement opportunities.
• Collaborate with cross-functional teams including Manufacturing, Process Development, Quality, and Engineering.
• Prepare, review, and maintain GDP-compliant technical documentation.
• Analyze process data and trends using available systems.
• Support Lean manufacturing and operational excellence initiatives.
• Prepare technical reports and management presentations.
• Ensure compliance with regulations and quality standards.

Skills

Bilingual: English/Spanish

Technical writing

Presentation skills

Team collaboration

Independent work

Time management

Problem solving

Education

Bachelor's degree in Engineering or Life Sciences

Tools

TrackWise

Veeva

MES

SmartSheet

ChatGPT

Copilot

Power BI

Spotfire

CDOCS

Process monitoring tools

Job description

Mentor Technical Group seeks a process-focused engineer to support biologics manufacturing operations in a regulated environment. The role emphasizes investigations, GDP-compliant documentation, and collaboration across Manufacturing, Process Development, Quality, and Engineering to ensure compliance and product quality.

You will monitor processes, perform root cause analyses, and contribute to Lean initiatives, presenting technical findings and recommendations.