GMP Process Engineer – Troubleshooting & Validation

QRC Group, LLC; Juncos (PR); On-site; USD 80,000 - 105,000; Full time

Job summary

QRC Group, LLC in Juncos, Puerto Rico seeks an Engineer with experience in regulated industry to provide solutions to technical problems of moderate scope and complexity, evaluate and apply standard engineering techniques, and function as a technical expert during troubleshooting.

The role collaborates with manufacturing, maintenance, process development, utilities, facilities, quality assurance and validation teams to support deviations, equipment qualification and process validation, design

Qualifications

• Masters or Bachelors in Engineering with 2 years of engineering experience.
• Educational background in Mechanical, Electrical and/or Chemical Engineering.
• Experience in equipment/process troubleshooting in a regulated environment.
• Knowledge of pharmaceutical/biotech processes and GMP production operations.
• Organizational and technical writing skills.
• Proficient presentation & communication skills in English and Spanish.
• Willingness to support 7/24 non-standard shift.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity.
• Under general supervision, evaluate, select and apply standard engineering techniques, basic principles and procedures.
• Function as a technical expert to process, equipment and/or systems during troubleshooting operations.
• Frequently become actively involved in daily operations to meet schedules or resolve sophisticated problems.
• Routinely supervise manufacturing processes for performance indicators and operations; suggest resolutions and provide mentorship.
• Collaborate with manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments.
• Support the execution of manufacturing/quality systems such as deviations, equipment qualification and/or process validation, procedures, training, and new product introductions.
• Apply process, operational, scientific expertise and analytical skills to support manufacturing operations.
• Organize, analyze and present interpretation of results for operational issues or engineering projects of moderate scope and complexity.
• Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.

Skills

Troubleshooting

Engineering fundamentals

Bilingual English/Spanish

Communication skills

Documentation/writing

Education

Master's degree in Engineering

Bachelor's degree in Engineering

Job description

QRC Group, LLC in Juncos, Puerto Rico seeks an Engineer with experience in regulated industry to provide solutions to technical problems of moderate scope and complexity, evaluate and apply standard engineering techniques, and function as a technical expert during troubleshooting.

The role collaborates with manufacturing, maintenance, process development, utilities, facilities, quality assurance and validation teams to support deviations, equipment qualification and process validation, design