Manufacturing Engineer

Flexible & Integrated Technical Services, LLC•Juncos, PR
•Onsite

About The Position

Engineer to provide technical support to 24/7 manufacturing operations. This role involves providing solutions to a variety of technical problems of moderate scope and complexity. The engineer will evaluate, select, and apply standard engineering techniques, basic principles, and procedures, with assistance given for unusual problems. The position functions as a technical expert for process, equipment, and/or systems during troubleshooting operations and multi-functional discussions. The role may require active involvement in daily operations to meet schedules or resolve sophisticated problems, and routine supervision of manufacturing processes for performance indicators and operations, including suggesting problem resolution and providing troubleshooting mentorship. Collaboration with manufacturing, maintenance, process development, utilities, facilities, quality assurance, and/or validation departments is expected for developing requirements and recommendations for process and/or system modifications. The role also supports the execution of manufacturing/quality systems such as deviations, equipment qualification and/or process validation, procedures, training, and new product introductions. The engineer will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. Additionally, the role involves organizing, analyzing, and presenting interpretations of results for operational issues or engineering projects of moderate scope and complexity, and applying basic engineering principles to the design and implementation of system modifications, experiments, and/or capital projects.

Requirements

  • Master's degree in Engineering, or a Bachelor's in Engineering plus 2 years of engineering experience within the Medical Devices or Pharmaceutical industry.
  • Bilingual (English/Spanish)
  • Strong presentation and communication skills.
  • Proactive and task-oriented.

Nice To Haves

  • Validation protocol writing and execution
  • Experience with documentation in highly regulated environments
  • Exposure to capital projects or system modifications

Responsibilities

  • Provide solutions to a variety of technical problems of moderate scope and complexity.
  • Evaluate, select and apply standard engineering techniques, basic principles and procedures.
  • Function as a technical expert to process, equipment and/or systems during troubleshooting operations and multi-functional discussions.
  • Become actively involved in daily operations when required to meet schedules or to resolve sophisticated problems.
  • Supervise manufacturing processes for performance indicators and operations.
  • Suggest problem resolution and provide troubleshooting mentorship.
  • Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for process and/or system modifications.
  • Support the execution of manufacturing/quality systems such as deviations, equipment qualification and/or process validation, procedures, training, and new product introductions.
  • Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
  • Organize, analyze and present interpretation 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 and/or capital projects.
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