JT755 - ENGINEER

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 80,000 - 115,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented engineer to join our team operating in Puerto Rico and the USA, working in a world-class pharmaceutical/biotech manufacturing environment. You will apply engineering principles to process and equipment challenges and support continuous improvement.

Responsibilities include troubleshooting, deviations, validations, and collaboration with QA, facilities, and vendors.

Qualifications

• Bachelor’s degree in Engineering and 2 years of engineering experience.
• Experience as a System Owner in a Manufacturing Management Platform (MMP) environment.
• Working knowledge of cGMP in pharmaceutical/biotech manufacturing.
• Experience using IBM Maximo CMMS.
• Ability to create, process, and manage POs.
• Ability to coordinate vendors in a regulated manufacturing environment.
• Flexibility to support 24/7 manufacturing operations, including after-hours support.

Responsibilities

• Provide solutions to technical problems of moderate scope and complexity.
• Evaluate and apply standard engineering techniques under supervision.
• Act as a technical expert for process, equipment, and systems during troubleshooting.
• Supervise manufacturing processes and contribute to performance improvements.
• Collaborate with manufacturing, maintenance, process development, utilities, facilities, QA and validation teams.
• Support deviations, equipment qualification, process validation, procedures, training and new product introductions.
• Apply engineering principles to design and implement system modifications and capital projects.
• Present results and interpretations for operational issues or projects.

Education

Bachelor’s degree in Engineering

2 years of Engineering experience

Tools

IBM 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, analyses 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.