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Senior Maintenance Engineer

2 months ago

Thousand Oaks, California, United States EPITEC Full time
Job Summary

This is a challenging engineering role that supports manufacturing activities associated with cGMP equipment and facilities for a leading pharmaceutical company. The senior engineer will work in partnership with various departments to develop and oversee the operation and reliability of equipment while driving safety and quality compliance.

Key Responsibilities
  • Develop and implement strategies to improve equipment reliability and reduce downtime
  • Collaborate with cross-functional teams to identify and address quality and safety risks
  • Design and implement modifications to address risks and improve quality and safety
  • Develop and oversee the commissioning strategy for new equipment and facilities
  • Oversee the development of validation protocols and ensure compliance with cGMP standards
  • Provide technical guidance and support to manufacturing and maintenance teams
  • Participate in internal audits and assess compliance with quality and safety standards
Requirements
  • Bachelor's degree in engineering or a related field
  • 7+ years of relevant work experience with 5+ years in operations/manufacturing environment
  • Direct experience with regulated environments (FDA, OSHA, EPA, etc.)
  • Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes
  • Experience implementing risk-based verification on major GMP process equipment/automation projects
  • Strong process equipment knowledge – cell culture, fermentation, purification, filling, and packaging
  • Strong process automation knowledge – understanding of automation infrastructure, current technologies, and automation project execution/verification
Preferred Qualifications
  • Knowledge of Delta V, Rockwell, and Plant Information Systems
  • Experience in developing SOPs and delivering training
  • Proven track record of applying process improvement methodologies to mature and improve business processes

This is an exciting opportunity for a skilled engineer to join our team at EPITEC and contribute to the development and implementation of innovative solutions to drive business growth and improvement.