JT778 - ENGINEER
Hace 3 semanas
Juncos, Puerto Rico
Quality Consulting Group, LLC
Jornada completa
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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:
• 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
Qualifications:
• 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.
• Administrative Shift
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
Qualifications:
• 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.
• Administrative Shift