Pharma Manufacturing Engineer — GMP & 24/7 Ops

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to join our team in Puerto Rico & USA. You will provide technical engineering support to manufacturing operations, troubleshoot processes, and drive improvements while ensuring GMP compliance.

The role requires collaboration with multiple functions, occasional non-standard shifts, and strong English/Spanish communication skills. Prior experience in regulated manufacturing is essential.

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Chemical Engineering.
• Experience with equipment and/or process troubleshooting in a regulated manufacturing environment.
• Knowledge of pharmaceutical and/or biotechnology processes and GMP production operations.
• Understanding of engineering principles, manufacturing processes, and equipment/system operations.
• Strong organizational and technical writing skills.
• Proficient presentation and communication skills in English and Spanish.
• Strong analytical and problem-solving skills.
• Ability to work with cross-functional teams including Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation.
• Ability to support manufacturing operations during non-standard shifts, including nights, weekends, and extended hours.

Responsibilities

• Provide technical engineering support to daily manufacturing operations, including troubleshooting, process optimization, equipment upgrades, replacements, and modifications.
• Ensure manufacturing activities are performed in compliance with corporate policies, industry standards, GMP requirements, and applicable regulatory requirements.
• Provide solutions to technical problems of moderate scope and complexity under general supervision.
• Evaluate, select, and apply standard engineering techniques, basic principles, and procedures to resolve operational issues.
• Serve as a technical resource for processes, equipment, and systems during troubleshooting activities and cross-functional discussions.
• Become actively involved in daily manufacturing operations when needed to meet production schedules or resolve complex technical issues.
• Monitor manufacturing processes and performance indicators and provide recommendations for problem resolution and process improvement.
• Provide troubleshooting guidance and mentorship to manufacturing personnel and other team members.
• Collaborate with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation to develop requirements and recommendations for process and system modifications.
• Support manufacturing and quality systems, including deviations, equipment qualification, process validation, procedures, training, and New Product Introductions (NPI).
• Apply process, operational, scientific, compliance, analytical, and troubleshooting expertise to support manufacturing operations.
• Organize, analyze, and present results and recommendations related to operational issues and engineering projects.
• Apply engineering principles to the design and implementation of system modifications, experiments, and capital projects.

Skills

Technical engineering support

Process optimization

Troubleshooting

Cross-functional collaboration

Regulatory compliance

English & Spanish communication

Analytical thinking

Education

Bachelor’s degree in Mechanical, Electrical, Chemical Engineering

Job description

Quality Consulting Group, LLC is seeking a talented engineer to join our team in Puerto Rico & USA. You will provide technical engineering support to manufacturing operations, troubleshoot processes, and drive improvements while ensuring GMP compliance.

The role requires collaboration with multiple functions, occasional non-standard shifts, and strong English/Spanish communication skills. Prior experience in regulated manufacturing is essential.