Senior Facilities Engineer, Sterile Manufacturing

BioSpace

Charlottesville (VA)

On-site

USD 50,000 - 70,000

Full time

2 days ago
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Job summary

Afton Scientific is seeking an experienced and highly skilled Senior Facilities Engineer to join our Facilities team. This position plays a critical role in maintaining safe, reliable, and compliant manufacturing operations by providing hands-on technical support for pharmaceutical process and production equipment.

The Senior Facilities Engineer will work closely with Manufacturing, Engineering, Facilities, MS&T, EHS, and other support functions to troubleshoot equipment issues, minimize

Qualifications

  • High school diploma with at least six years of experience performing maintenance on manufacturing equipment.
  • Experience working in a sterile fill-finish manufacturing environment.
  • Strong understanding of GMP standards, regulatory requirements and industry best practices.
  • Demonstrated ability to work independently while following established procedures and operational practices.
  • Background in continuous process improvement.

Responsibilities

  • Serve as a technical resource to production teams and provide hands-on support for pharmaceutical process equipment.
  • Act as a first responder for manufacturing equipment malfunctions and drive timely troubleshooting and resolution.
  • Support equipment including fill lines, isolators, parts washers, autoclaves, and other production-related machinery.
  • Work with equipment owners, engineers, vendors, and other technical resources to diagnose and resolve equipment issues.
  • Support preventive maintenance and calibration activities for manufacturing equipment.
  • Develop and update preventive maintenance instructions and help maintain appropriate inventories of critical spare parts.
  • Complete work orders, GMP records, and other required documentation accurately and on time.
  • Proactively identify recurring or emerging equipment issues and partner with support teams to develop sustainable solutions.
  • Support onboarding and technical training of Manufacturing personnel on process equipment.
  • Assist MS&T with new product introductions and technology-transfer activities.
  • Support the revision and management of manufacturing documentation, including Batch Records and SOPs.
  • Adapt to changing production schedules and reprioritize work to minimize operational disruptions.
  • Participate in periodic on-call rotations to monitor and respond to equipment issues.

Skills

Technical Troubleshooting
Problem Solving
Independent Judgment
GMP Compliance
Documentation
Equipment Reliability
Safety & Risk Awareness
Communication & Collaboration
Planning & Prioritization
Continuous Improvement
Adaptability & Initiative

Education

Associate degree or higher in Pharmaceutical Sciences, Engineering, or related field

Tools

CMMS
Microsoft Office

Job description

Afton Scientific is seeking an experienced and highly skilled Senior Facilities Engineer to join our Facilities team. This position plays a critical role in maintaining safe, reliable, and compliant manufacturing operations by providing hands-on technical support for pharmaceutical process and production equipment.

The Senior Facilities Engineer will work closely with Manufacturing, Engineering, Facilities, MS&T, EHS, and other support functions to troubleshoot equipment issues, minimize

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