Senior Manager Site Engineering

1 day ago


Memphis, Tennessee, United States Charles River Full time
About the Role

Charles River is seeking a Senior Manager Site Engineering to establish and maintain engineering for utility and process equipment and systems to support current Good Manufacturing Practices (cGMP) operations.

Key Responsibilities
  • Manage equipment life cycle programs, tech transfer assessments, and control systems for production equipment, QC laboratory equipment, utilities, and data management systems in collaboration with other departments.
  • Oversee the utility and process engineering teams and collaborate with maintenance and calibration activities between project teams, consultants, and contractors during new construction and ongoing production.
  • Ensure compliance with all local and state safety requirements and create a zero-injury mindset at every level of the organization.
  • Establish and build an effective team to deliver tech transfers, best-in-class equipment selection, and equipment life cycle management.
  • Maintain Building Management System (BMS) system and drive equipment utilization.
  • Lead technical discussions on complex system issues, make recommendations, suggestions, and report progress to site leadership.
  • Create and execute comprehensive technical documents, including SOPs, along with risk and lifecycle management documents for site, manufacturing, and QC equipment as necessary.
Requirements
  • Bachelor's degree, preferred, or relevant years of experience within scope.
  • 12 years of relevant experience in engineering.
  • Minimum 8 years of prior supervisory/management experience.
  • Extensive knowledge of utility maintenance, metrology, building, and preventative maintenance programs, cleanroom operations, water systems, and applicable regulations and local codes.
  • Strong troubleshooting and problem-solving skills, with the ability to lead or participate in issue resolution meetings.
  • Strong interpersonal communication skills, with the ability to effectively communicate (both oral and written) across all levels of the organization.
  • Demonstrated technical writing and clear documentation skills.
  • Ability to manage multiple and changing priorities and to quickly make decisions that protect people, equipment, and facilities while keeping downtime and costs in mind.
  • Ability to interpret and apply GMPs, relevant laws, guidance, and directives to sometimes complex situations.
About Charles River

Charles River is an early-stage contract research organization (CRO) with a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.

We have a strong sense of purpose and approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe.

We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.

Benefits

We offer a range of benefits, including bonus/incentives based on performance, 401K, paid time off, stock purchase program, health and wellness coverage, employee and family wellbeing support programs, and work-life balance flexibility.



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