Manufacturing Engineering Professional

5 days ago

Mansfield, Ohio, United States Volt Workforce Solution Full time
Job Summary

Volt Workforce Solutions is currently hiring a highly skilled Manufacturing Engineer to join our team in Mansfield, MA. As a key member of our production team, you will be responsible for creating, updating, and maintaining equipment service work instructions, organizing and writing validation protocols associated with the manufacturing process, and leading troubleshooting activities to minimize process downtime or reoccurrence.

Key Responsibilities:
  • Create, update, and maintain equipment service work instructions to ensure efficient and effective manufacturing processes.
  • Organize and write validation protocols associated with the manufacturing process to ensure compliance with regulatory requirements.
  • Lead and support troubleshooting activities to minimize process downtime or reoccurrence, using analytical and problem-solving skills to identify root causes and implement corrective actions.
  • Identify key process indicators and collect data to drive manufacturing and yield improvements, analyzing results to inform decision-making and optimize processes.
  • Generate and execute validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on sterilization and microbiology of medical devices, ensuring compliance with regulatory requirements and industry standards.
  • Develop statistically based sampling plans for in-process and final testing and inspections, and validations, applying statistical principles to ensure accuracy and reliability.
  • Troubleshoot equipment/processes that do not perform as intended during validation runs, using technical expertise and problem-solving skills to resolve issues efficiently.
  • Recommend process/quality improvements as part of validation runs, identifying opportunities for optimization and implementing changes to improve overall efficiency and quality.
  • Evaluate, investigate, and document non-conformances incidents and/or protocol deviations, taking corrective action to prevent recurrence and maintain compliance.
  • Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports, communicating findings and recommendations to stakeholders.
Requirements:
  • Bachelor's degree in Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.
  • Lean/Six Sigma Green or Black Belt Certification is a plus.
  • Minimum of 4 years of experience in the medical device and/or pharmaceutical manufacturing environment.
  • Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements, ensuring compliance with regulatory standards.
  • Strong Project Management skills, able to lead teams through complex projects and provide departmental technical leadership.
  • Excellent communication skills, with a strong track record of working cross-functionally, building relationships with internal departments, external vendors, and customers.
  • Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
Estimated Salary Range:

$45-$55 per hour, depending on education, work experience, location, and specific job duties.

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