JT778 - ENGINEER
About The Position
Quality Consulting Group is seeking a motivated Engineer to provide technical support for pharmaceutical, biotechnology, medical device, and manufacturing operations in Puerto Rico and the United States. The position supports daily manufacturing operations, with a focus on biotechnology purification processes, equipment performance, process optimization, troubleshooting, and engineering improvements. The Engineer collaborates across manufacturing and technical functions, supports qualification and validation activities, and helps ensure compliance with GMP/GLP requirements and applicable regulations. The role supports 24/7 manufacturing operations and may require non-standard shifts, extended hours, nights, or weekends.
Requirements
- Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Industrial, or related field).
- Experience in biotechnology processes, specifically in purification operations.
- Knowledge of chromatography and Ultrafiltration/Diafiltration (UF/DF) techniques.
- Understanding of purification equipment, processes, and operational best practices within a biotechnology manufacturing environment.
- Ability to follow GMP/cGMP procedures and documentation requirements in purification operations.
- Strong troubleshooting and problem-solving skills related to purification processes.
Responsibilities
- Provide technical engineering support to daily manufacturing operations, including troubleshooting, process optimization, upgrades, replacements, and equipment modifications.
- Serve as a technical resource for equipment, processes, and systems during troubleshooting and cross-functional discussions.
- Monitor manufacturing processes and equipment performance, identify operational issues, and recommend solutions.
- Collaborate with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation teams on process and system improvements.
- Support deviations, equipment qualification, process validation, procedures, training, and New Product Introduction activities.
- Analyze operational data and present findings and recommendations for engineering projects and manufacturing issues.
- Apply engineering principles to system modifications, experiments, equipment improvements, and capital projects.
- Support design and construction projects, including reviewing technical documents, equipment quotes, project schedules, and cost estimates.
- Evaluate and resolve technical problems using analytical and troubleshooting skills while working under general supervision.
- Ensure manufacturing activities comply with corporate policies, industry standards, GMP/GLP requirements, and applicable regulatory expectations.
- Provide engineering support for 24/7 manufacturing operations, including non-standard shifts, extended hours, nights, and weekends as required.
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What This Job Offers
Job Type
Full-time
