The Role
Leads engineering and equipment reliability initiatives in pharmaceutical manufacturing, including process optimization, troubleshooting, maintenance strategy development, equipment performance analysis, and capital projects. Manages CMMS work orders, preventive maintenance, spare parts, change control, deviations, CAPAs, and compliance activities. Serves as a manufacturing equipment SME, supervises engineers and technicians, and drives improvements in equipment availability, downtime reduction, system reliability, GMP compliance, and EHS performance.
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:
- Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment.
- Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects.
- Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.
- Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
- Develop engineering policies and procedures that affect multiple organizational units.
- Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
- Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
- Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
- Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
- Application of mature engineering knowledge in planning and conducting projects.
- Bachelor Degree in Engineering
- 5 years of Engineering experience
- Experience managing manufacturing equipment within a Computerized Maintenance Management System (CMMS), including work order approval and closure, preventive maintenance (PM) strategy development, and spare parts management.
- Knowledge of equipment reliability principles, maintenance optimization, and change control processes.
- Ability to collaborate effectively with Engineering and cross-functional teams to develop and implement maintenance strategies that improve equipment performance.
- Experience driving initiatives focused on increasing equipment availability, reducing downtime, and improving system reliability.
- Proficiency in developing, analyzing, and reporting equipment performance metrics, including availability, downtime, and maintenance effectiveness.
- Proven experience leading equipment improvement and reliability enhancement projects.
- Strong technical expertise serving as a Subject Matter Expert (SME) for manufacturing equipment design, maintenance, and compliance activities.
- Experience troubleshooting manufacturing equipment and supporting root cause investigations.
- Knowledge of deviation management and experience developing, implementing, and monitoring Corrective and Preventive Actions (CAPAs).
- Understanding of Good Manufacturing Practices (GMP) and regulatory compliance requirements within a manufacturing environment.
- Commitment to Environmental, Health, and Safety (EHS) standards and demonstrated ability to promote a safe working environment.
- Strong analytical, problem-solving, organizational, and communication skills.
- Ability to manage multiple priorities and work effectively in a fast-paced manufacturing environment.
Skills Required
- Bachelor's degree in Engineering
- At least 5 years of engineering experience
- Experience managing manufacturing equipment in a CMMS, including work order approval and closure, preventive maintenance strategy development, and spare parts management
- Knowledge of equipment reliability principles, maintenance optimization, and change control processes
- Experience collaborating with engineering and cross-functional teams to develop and implement maintenance strategies
- Experience driving initiatives to increase equipment availability, reduce downtime, and improve system reliability
- Experience developing, analyzing, and reporting equipment performance metrics
- Experience leading equipment improvement and reliability enhancement projects
- Technical expertise as an SME for manufacturing equipment design, maintenance, and compliance
- Experience troubleshooting manufacturing equipment and supporting root cause investigations
- Knowledge of deviation management and experience developing, implementing, and monitoring CAPAs
- Understanding of GMP and regulatory compliance requirements in manufacturing
- Commitment to EHS standards and promoting a safe work environment
- Strong analytical, problem-solving, organizational, and communication skills
- Ability to manage multiple priorities in a fast-paced manufacturing environment
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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
