JT626 - ENGINEER

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to join a world-class manufacturing team in Puerto Rico & USA. The role focuses on solving technical problems in a regulated pharma/biotech environment and supporting process improvements.

You will work with manufacturing, QA and validation teams, providing expertise in troubleshooting, equipment qualification and process validation while contributing to the smooth operation of manufacturing lines and quality systems.

Qualifications

• Bachelor’s in engineering with 2+ years engineering experience in a regulated environment.
• Background in Mechanical, Electrical and/or Chemical Engineering.
• Experience with pharmaceutical/biotech GMP processes.
• Strong writing and communication skills in English and Spanish.

Responsibilities

• Provide solutions to a variety of technical problems of moderate scope and complexity under general supervision.
• Function as a technical expert to support process, equipment and systems during troubleshooting operations and discussions.
• Frequently participate in daily operations to meet schedules or resolve sophisticated problems.
• Routinely supervise manufacturing processes for performance indicators and operations, suggesting resolutions.
• Collaborate with manufacturing, maintenance, process development, utilities, facilities, QA and validation to develop requirements and recommendations for process or system modifications.
• Support execution of manufacturing/quality systems such as deviations, equipment qualification and process validation, procedures and training.
• Apply engineering principles to design and implement system modifications, experiments and capital projects.
• Support 7/24 non-standard shift operation including extended hours and weekends.

Skills

Engineering troubleshooting

Regulated environment knowledge

Bilingual English/Spanish

Technical writing

Presentation skills

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.
• Educational background in Mechanical, Electrical and/or Chemical Engineering
• Experience with equipment and/or process troubleshooting in a regulated environment.
• Knowledge of pharmaceutical/biotech processes and GMP production operations.
• Organizational & technical writing skills.
• Proficient presentation & communication skills in English and Spanish
• Shift:5am and 5pm (2/3/2) days shift Example: Week 1: (Mon-Tues (12hrs shift)) / Fri-Sat-Sun (12 hrs shift) Week 2: Wed-Thurs( 12 hrs shift)

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.