JT958 - ENGINEER

Quality Consulting Group, LLC; Juncos (PR); Presencial; USD 80.000 - 110.000; Jornada completa

Descripción de la vacante

Quality Consulting Group, LLC is seeking a talented engineer to support daily manufacturing operations in a world-class facility in Puerto Rico and the USA.

The role requires a Bachelor’s degree in Engineering and hands-on experience with regulated pharma/biotech equipment, CAPAs, and IBM Maximo. You will collaborate across Manufacturing, Maintenance, Process Development, QA, and Validation teams to drive process improvements.

Formación

• Bachelor’s degree in Engineering in a related field.
• Experience supporting manufacturing equipment in regulated pharma/biotech.
• Knowledge of system owner assessments, CAPAs, and investigations.
• Experience with IBM Maximo for work orders and preventive maintenance.
• Ability to troubleshoot equipment failures and improve reliability.
• Experience developing preventive maintenance strategies and SOPs.

Responsabilidades

• Provide technical engineering support to daily manufacturing operations.
• Serve as a technical resource for equipment, processes, and systems.
• Monitor processes, identify issues, and propose solutions.
• Collaborate with cross-functional teams on process improvements.
• Support deviations, qualifications, validation, training, and NPI activities.
• Analyze data and present findings for projects.
• Ensure GMP/GLP compliance and regulatory expectations.
• Support 24/7 manufacturing operations including non-standard shifts.

Conocimientos

Troubleshooting

Root cause analysis

Cross-functional collaboration

Documentation

Educación

Bachelor’s degree in Engineering

Herramientas

IBM Maximo

Descripción del empleo

QUALITY CONSULTING GROUP, a leader inthe 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 supporting manufacturing equipment and systems in a regulated pharmaceutical or biotechnology environment.

• Knowledge of System Owner assessments, engineering impact assessments, technical investigations, CAPAs, and corrective/preventive actions.

• Experience with IBM Maximo, including work order management, maintenance coordination, and preventive maintenance programs.

• Ability to troubleshoot equipment failures, identify root causes, and implement equipment reliability improvements.

• Experience developing and revising preventive maintenance strategies, Job Plans, inspection requirements, and SOPs.

• Knowledge of biopharmaceutical manufacturing equipment, including centrifuges, autoclaves, process tanks, chromatography, UF/DF systems, and instrumentation.

• Experience supporting equipment upgrades, replacements, spare parts evaluations, and engineering improvement projects.

• Ability to prepare technical reports, maintain accurate documentation, and manage multiple projects simultaneously.

• Strong communication and collaboration skills when working with Manufacturing, Engineering, Maintenance, Quality, Automation, and Validation teams.

• Ability to prioritize assignments based on safety, quality, and operational requirements.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.