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Senior Manufacturing Engineer

2 months ago

Bedford, Bedford, United Kingdom Werfen Full time
Job Summary

This role requires a unique blend of technical expertise and leadership skills to drive manufacturing engineering activities and project management initiatives. As a Senior Manufacturing Engineer, you will apply advanced knowledge of engineering principles to solve complex problems and improve manufacturing processes. As a Project Manager, you will lead cross-functional teams to deliver projects on time, within budget, and to the required quality standards.

Key Responsibilities
  • Provide technical leadership to cross-functional project teams to ensure design requirements are met and comply with applicable standards.
  • Coordinate technical resources to identify and resolve project issues, develop and implement solutions, and ensure project risks are mitigated.
  • Develop and implement process controls for product transfer to manufacturing or new manufacturing sites.
  • Write, review, and approve validations, SOPs, and technical reports for new products, processes, and equipment.
  • Ensure all projects and processes comply with FDA, GMP, QSR, ISO, and other applicable requirements.
  • Identify and implement opportunities for continuous improvement.
Requirements
  • Bachelor's degree in engineering; advanced degree a plus.
  • Eight years of previous manufacturing engineering experience preferred.
  • Previous experience in a regulated medical device or pharmaceutical environment.
  • Full and comprehensive knowledge of the product lifecycle, including product development from conception to manufacturing introduction.
  • Experience in creating and understanding engineering drawings, schematics, specifications, tolerancing, and bills of materials.
  • Expertise in writing and performing validations in a regulated environment.
  • Knowledge of statistical sampling and analysis.
  • Understanding of FDA, GMP, ISO, and OSHA regulations.
Travel Requirements

Approximately 20% international mobility required.