JT737 - ENGINEER

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Quality Consulting Group, LLC, a leader in the pharmaceutical, biotech, medical devices, and manufacturing sector, seeks an engineer to join our Puerto Rico/USA team. You will address technical challenges, support deviations and qualifications, and collaborate across QA, validation, and operations to optimize processes and equipment.

The role requires a Bachelor’s in engineering with GMP experience, strong English/Spanish communication, and a proactive, problem-solving mindset.

Qualifications

• Bachelor’s degree in engineering with 2 years of experience.
• Experience in GMP-regulated pharmaceutical/biotech environment.
• Strong English and Spanish communication.

Responsibilities

• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Function as a technical expert to process, equipment and/or systems during troubleshooting operations and multi-functional discussions.
• Frequently become actively involved in daily operations when required to meet schedules or to resolve sophisticated problems.
• Routinely supervise manufacturing processes for performance indicators and operations.
• Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for process and/or system modifications.
• 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, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations
• Organizes, analyzes and presents 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.
• Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.

Skills

GMP experience

Bilingual English/Spanish

Root-cause analysis

Design of Experiments

CAPA management

Technical writing

Problem solving

Packaging equipment knowledge

Education

Bachelor’s in engineering

Job description

QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities

• Provide solutions to a variety of technical problems of moderate scope and complexity.
  Under general supervision will 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 become actively involved in daily operations when required to meet schedules or to resolve sophisticated problems.
• Routinely supervise manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship.
• Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and
  recommendations for process and/or system modifications.
• 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, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations
• Organizes, analyzes and presents 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.
• Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.

Qualifications

• Bachelor’s in engineering + 2 years of Engineering experience.
• Experience working in a GMP-regulated environment within the pharmaceutical, medical device, or biotechnology industry.
• Proficiency in technical report writing and documentation.
• Strong verbal and written communication skills in both English and Spanish.
• Knowledge of packaging equipment, process characterization, validation, process monitoring, and optimization techniques.
• Demonstrated problem-solving skills with experience conducting root cause investigations.
• Experience identifying, implementing, and managing Corrective and Preventive Actions (CAPAs).
• Proficiency in statistical analysis and Design of Experiments (DOE) methodologies.
• Ability to apply engineering principles to troubleshoot and resolve technical issues in a manufacturing or production environment.
• Flexibility and availability to support non-standard shifts, including extended hours, nights, weekends, and holidays as needed.
• Shift: 1st or 2nd

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.