GMP Process Engineer - Pharma Ops & Troubleshooting

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to join our team in Puerto Rico and the USA. You will provide technical engineering support to daily manufacturing operations and help optimize processes while ensuring compliance with GMP and regulatory requirements.

The role emphasizes collaboration with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation, and requires bilingual English/Spanish communication and flexibility for

Qualifications

• Bachelor's degree in Mechanical, Electrical, or 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.
• Strong organizational and technical writing skills.
• Proficient English and Spanish communication.
• Ability to work non-standard shifts, including nights and weekends.
• Ability to collaborate with cross-functional teams and support multiple manufacturing operations.

Responsibilities

• Provide technical engineering support to daily manufacturing operations, including troubleshooting, process optimization.
• Ensure manufacturing activities comply with GMP, corporate policies, industry standards, and applicable regulatory requirements.
• Serve as a technical resource for processes, equipment, and systems during troubleshooting and cross-functional discussions.
• Monitor manufacturing processes and performance indicators and provide recommendations for problem resolution and process improvement.
• Support deviations, equipment qualification, process validation, procedures, training, and NPI as needed.
• Collaborate with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation to develop requirements and recommendations for process and system modifications.

Skills

Troubleshooting

Cross-functional collaboration

Bilingual English/Spanish

Process optimization

Regulatory compliance

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 and the USA. You will provide technical engineering support to daily manufacturing operations and help optimize processes while ensuring compliance with GMP and regulatory requirements.

The role emphasizes collaboration with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation, and requires bilingual English/Spanish communication and flexibility for