The Role
Supports pharmaceutical manufacturing operations through troubleshooting, process and equipment improvements, validation, qualification, deviations, system modifications, and capital projects. Serves as a technical expert for manufacturing systems and collaborates with maintenance, quality, facilities, utilities, and process development teams. Monitors operational performance, mentors troubleshooting activities, manages vendors and purchase orders, and provides engineering support for 24/7 manufacturing operations.
Summary Generated by Built In
QUALITY CONSULTING GROUP, a leader in the 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:
Qualifications:
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.
Skills Required
- Bachelor's degree in Engineering
- Two years of engineering experience
- Experience as a System Owner in a Manufacturing Management Platform environment
- Working knowledge of current Good Manufacturing Practices and engineering practices related to pharmaceutical or biotechnology manufacturing processes, facilities, and equipment
- Experience using IBM Maximo Computerized Maintenance Management System
- Ability to create, process, and manage purchase orders
- Experience coordinating, supporting, and escorting external vendors and contractors in a regulated manufacturing environment
- Ability to manage multiple tasks, projects, and priorities simultaneously in a fast-paced environment
- Flexibility to support 24/7 manufacturing operations, including occasional after-hours engineering support
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The Company
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
