JT755 - ENGINEER

qualityconsultinggroup; Juncos (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to join our team, contributing in a world-class manufacturing environment across Puerto Rico and the United States. In this role, you’ll work with a highly motivated team, solving technical problems and supporting process improvements in pharma, biotech, medical devices and related manufacturing sectors.

You will evaluate, apply standard engineering methods, support deviations and qualification activities, and collaborate with multiple

Qualifications

• Bachelor’s degree in Engineering with 2+ years of engineering experience.
• Experience as a System Owner in a Manufacturing Management Platform (MMP) environment.
• Working knowledge of cGMP in pharmaceutical/biotechnology manufacturing.
• Experience coordinating external vendors in a regulated setting.
• Ability to manage multiple tasks and priorities in a fast-paced environment.
• Flexibility to support 24/7 manufacturing operations including after-hours.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity under supervision.
• Serve as a technical expert for processes, equipment, and systems during troubleshooting.
• Participate in daily operations to meet schedules and resolve complex issues.
• Supervise manufacturing processes for performance indicators and mentorship.
• Collaborate with manufacturing, maintenance, process development, utilities, facilities, QA and validation.
• Support deviations, equipment qualification, process validation, procedures and training.
• Apply engineering principles to design system modifications and capital projects.
• Analyze results for operational issues or engineering projects of moderate scope.

Skills

cGMP knowledge

Analytical skills

Troubleshooting

Multitasking

Vendor coordination

System Owner experience

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

2 years of Engineering experience

Tools

Maximo CMMS

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 degree in Engineering & 2 years of Engineering experience
• Experience as a System Owner in a Manufacturing Management Platform (MMP) environment.
• Working knowledge of current Good Manufacturing Practices (cGMP) and engineering practices related to pharmaceutical/biotechnology manufacturing processes, facilities, and equipment.
• Experience using IBM Maximo Computerized Maintenance Management System (CMMS).
• Ability to create, process, and manage Purchase Orders (POs).
• Experience coordinating, supporting, and escorting external vendors and contractors in a regulated manufacturing environment.
• Strong ability to manage multiple tasks, projects, and priorities simultaneously in a fast-paced environment.
• Flexibility to work a schedule that supports 24/7 manufacturing operations, including occasional after-hours engineering support when required.

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.