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Initial Therapeutics, Inc.

Senior Facilities Engineer

virginia, MN

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Job description

Afton Scientific is a contract manufacturing organization (CMO) in Virginia that specializes in small-batch filling of injectables from clinical trials to approved commercial drugs.

Utilizing 35,000 Sq. Ft of manufacturing, lab, warehouse, and administrative space, Afton provides custom, innovative solutions for clinical to commercial sterile manufacturing, packaging and labeling, analytical and micro lab services, and pharmaceutical support services.

Our Ready-To-Fill® line continues with our philosophy of guidance and support for our clients. It offers top-quality pre-sterilized components to those who can fill in-house.

Serving clients in 18 Countries

Successful NDA and ANDA drug registrations

In good standing with the FDA, PMDA, and MHRA

NOTE: Afton Scientific does not sponsor work visas. No recruiters please.

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 production disruptions, strengthen preventive maintenance practices, and support the continued growth of Afton’s sterile manufacturing operations.

Compensation

$36.00 – $50.48 per hour

Placement within the range will be based on qualifications, relevant experience, internal equity, and demonstrated competencies.

Primary 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.

Minimum Qualifications

High school diploma with at least six years of experience performing maintenance on manufacturing equipment, or an Associate degree or higher in Pharmaceutical Sciences, Engineering, or a related field.

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.

Strong communication and collaboration skills with a commitment to maintaining high-quality standards.

Preferred Knowledge and Experience

Understanding of high-speed aseptic filling operations and isolator barrier-system technologies.

Experience with single-use components used in drug-product formulation, sterile filtration, and aseptic filling.

Proficiency with Computerized Maintenance Management Systems (CMMS).

Proficiency with Microsoft Office.

Demonstrated experience troubleshooting complex pharmaceutical manufacturing equipment.

Experience developing or improving preventive maintenance practices.

Key Competencies

Technical Troubleshooting & Problem Solving

Critical & Analytical Thinking

Independent Judgment

GMP Compliance & Documentation

Equipment Reliability

Safety & Risk Awareness

Communication & Collaboration

Planning & Prioritization

Continuous Improvement

Adaptability & Initiative

What You'll Gain

The opportunity to work directly with critical equipment supporting sterile pharmaceutical manufacturing.

Significant involvement in troubleshooting, equipment reliability, preventive maintenance, and continuous improvement.

Exposure to aseptic filling technologies, isolator systems, new product introductions, and technology transfers.

Opportunities to collaborate across Manufacturing, Engineering, MS&T, EHS, and Facilities.

Continued technical and professional development within Afton Scientific.

Physical & Work Requirements

This position requires the ability to work in a manufacturing environment and frequently use hands and fingers to operate tools, equipment, and controls. Employees may occasionally be required to stand, walk, sit, reach, and lift or move up to 40 pounds . Extended computer use and data analysis may also be required.

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Worksite address

virginia, MN, 55792, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.

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