Senior Manufacturing Engineer - GMP Pharma, 24/7 Ops

Quality Consulting Group, LLC

Juncos (PR)

On-site

USD 85,000 - 115,000

Full time

6 days ago

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Job summary

Quality Consulting Group, LLC is seeking a driven engineering professional to join our team supporting 24/7 pharmaceutical and biotech manufacturing operations in Puerto Rico and the United States. The role focuses on technical engineering support, equipment reliability, and process improvements.

You will collaborate with Manufacturing, Maintenance, Quality, and Validation to ensure GMP/GLP compliance and successful deviations and validations.

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 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.

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.