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Resilience US2 days ago

Manager, Engineering

$105,000–$138,750 year

On-site · West Chester, Ohio, United States

Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Unknown

Job Summary

Manager, Engineering responsible for owning all assets and ensuring operation and maintenance of a PET/Facility process, scheduling maintenance, coordinating technical resources, and guiding troubleshooting. Leads improvement initiatives as the technical expert and acts as the first line of support for project work. Primarily supports Inspection Operations at the West Chester Manufacturing Site. Responsibilities include ensuring validated processes with clear CPs and specs, owning asset reliability and lifecycle management, developing engineering proposals, providing technical guidance and performance management for engineering staff, ensuring cross-shift technical support, updating documentation and systems, adhering to EHS and GMP, performing risk analyses on spare parts, driving CAPAs and root-cause investigations, identifying training needs, collaborating with PET/Facility and MSAT teams, authoring SOPs, batch records, validation docs, and change controls, and providing input on new asset procurement. The role requires collaboration with suppliers and regulatory inspections as the technical process owner.

Required Qualifications

  • Experience in GMP or regulated production environment
  • Previous supervisory experience
  • Knowledge of FDA cGMP
  • Strong communication and leadership skills
  • Problem solving skills
  • Expertise in two or more of: equipment, process/materials, maintenance, project delivery, automation/controls, and validation

Additional Requirements

  • Sponsorship or support for work authorization, including visas, is not available for this position.
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$105k – $139k / yr

Manager, Engineering · Resilience US

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