Pharma Process Engineer - 24/7 Operations, Bilingual

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to join a world-class manufacturing team in Puerto Rico & USA. The role focuses on solving technical problems in a regulated pharma/biotech environment and supporting process improvements.

You will work with manufacturing, QA and validation teams, providing expertise in troubleshooting, equipment qualification and process validation while contributing to the smooth operation of manufacturing lines and quality systems.

Qualifications

• Bachelor’s in engineering with 2+ years engineering experience in a regulated environment.
• Background in Mechanical, Electrical and/or Chemical Engineering.
• Experience with pharmaceutical/biotech GMP processes.
• Strong writing and communication skills in English and Spanish.

Responsibilities

• Provide solutions to a variety of technical problems of moderate scope and complexity under general supervision.
• Function as a technical expert to support process, equipment and systems during troubleshooting operations and discussions.
• Frequently participate in daily operations to meet schedules or resolve sophisticated problems.
• Routinely supervise manufacturing processes for performance indicators and operations, suggesting resolutions.
• Collaborate with manufacturing, maintenance, process development, utilities, facilities, QA and validation to develop requirements and recommendations for process or system modifications.
• Support execution of manufacturing/quality systems such as deviations, equipment qualification and process validation, procedures and training.
• Apply engineering principles to design and implement system modifications, experiments and capital projects.
• Support 7/24 non-standard shift operation including extended hours and weekends.

Skills

Engineering troubleshooting

Regulated environment knowledge

Bilingual English/Spanish

Technical writing

Presentation skills

Education

Bachelor's in engineering

Job description

Quality Consulting Group, LLC is seeking a talented engineer to join a world-class manufacturing team in Puerto Rico & USA. The role focuses on solving technical problems in a regulated pharma/biotech environment and supporting process improvements.

You will work with manufacturing, QA and validation teams, providing expertise in troubleshooting, equipment qualification and process validation while contributing to the smooth operation of manufacturing lines and quality systems.