Regulated Industry Engineer | Pharma/Biotech Troubleshooter

QRC Group; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

QRC Group in Juncos, Puerto Rico, seeks an engineer for a regulated industry role. You will provide solutions to technical problems, evaluate standard techniques, and act as a technical expert during troubleshooting and cross-functional discussions.

Responsibilities include supervising manufacturing processes, collaborating with QA, process development, utilities, and validation teams, and supporting deviations, qualification and validation activities.

Qualifications

• Master's or Bachelor's in engineering with 2 years of experience in a regulated environment.
• Experience with equipment/process troubleshooting in a regulated environment.
• Knowledge of pharmaceutical/biotech processes and GMP production operations.
• Strong organizational and technical writing skills; proficient in English and Spanish; presentations encouraged.
• Willingness to support 7/24 non-standard shift as needed.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity.
• Under 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 and multi-functional discussions.
• Frequently involved in daily operations to meet schedules or resolve sophisticated problems.
• Routinely supervise manufacturing processes for performance indicators and provide mentoring.
• Work with manufacturing, QA, validation, and facilities on modifications and improvements.
• Support deviations, equipment qualification and process validation activities.
• Apply engineering principles to design and implement system modifications and capital projects.

Skills

Engineering expertise

Regulated industry experience

English and Spanish communication

Education

Master's or Bachelor's in Engineering

Job description

QRC Group in Juncos, Puerto Rico, seeks an engineer for a regulated industry role. You will provide solutions to technical problems, evaluate standard techniques, and act as a technical expert during troubleshooting and cross-functional discussions.

Responsibilities include supervising manufacturing processes, collaborating with QA, process development, utilities, and validation teams, and supporting deviations, qualification and validation activities.