JT878 - ENGINEER
About The Position
Quality Consulting Group is seeking an Engineer to support manufacturing operations in the pharmaceutical, biotechnology, medical device, and manufacturing industries in Puerto Rico and the United States. Under general supervision, the Engineer applies standard engineering techniques and basic principles to technical problems of moderate scope and complexity. The role provides technical expertise for processes, equipment, and systems, including troubleshooting and participation in cross-functional discussions. The Engineer supports facility systems—including HVAC and utilities—in a regulated environment, monitors manufacturing processes and performance indicators, and recommends solutions or modifications. The position also supports manufacturing and quality systems, such as deviations, equipment qualification, process validation, procedures, training, and new product introductions. Work may include system modifications, experiments, and capital projects. The role supports nonstandard 12-hour shifts, including extended hours and weekends as business needs require.
Requirements
- Bachelor’s degree in Engineering, such as Mechanical, Electrical, Chemical, Industrial, or a related field.
- Experience supporting HVAC, utilities, and facility systems in a regulated pharmaceutical or biotechnology environment.
- Knowledge of GMP requirements and applicable regulatory standards.
- Experience troubleshooting, optimizing, and modifying facility systems.
- Knowledge of preventive maintenance strategies, facility modifications, and capital projects.
- Ability to collaborate with cross-functional teams, including Facilities, Maintenance, Manufacturing, Quality, Validation, and EHS.
- Ability to coordinate with external engineering firms and service providers.
- Strong analytical, problem-solving, and communication skills.
Responsibilities
- Provide solutions to technical problems of moderate scope and complexity.
- Evaluate, select, and apply standard engineering techniques, basic principles, and procedures under general supervision.
- Serve as a technical expert for processes, equipment, and systems during troubleshooting and multifunctional discussions.
- Become involved in daily operations as needed to meet schedules or resolve complex problems.
- Monitor manufacturing processes for performance indicators and operations, suggest resolutions, and provide troubleshooting mentorship.
- Collaborate with manufacturing, maintenance, process development, utilities, facilities, quality assurance, and validation departments to develop requirements and recommendations for process or system modifications.
- Support manufacturing and quality systems, including deviations, equipment qualification, process validation, procedures, training, and new product introductions.
- Apply process, operational, scientific, compliance, analytical, and troubleshooting knowledge to support manufacturing operations.
- Organize, analyze, and present interpretations 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, or capital projects.
- Support 7/24 nonstandard shift operations, including extended hours and weekends, according to business needs.
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What This Job Offers
Job Type
Full-time
