The Facilities Engineer II plays a key role in ensuring compliant operations within a GMP pharmaceutical manufacturing environment. This position provides hands-on support across a broad range of service areas involving pharmaceutical process equipment, including, but not limited to fill lines, isolators, parts washers, autoclaves, and other production-related machinery. Working in a highly technical setting, Facilities Engineer IV must have experience maintaining safe, reliable production activities. The role requires strong critical-thinking skills and the ability to evaluate business impacts before acting, helping prevent unintended outcomes such as safety incidents, equipment failures, or other operational risks. The position also demands sound independent judgment and the ability to thrive in a dynamic, small-company environment where priorities can shift quickly. The ideal candidate has a proven history of delivering results in a fast-paced sterile manufacturing setting, while fostering a positive mindset and contributing to a strong, collaborative team culture.
Key Responsibilities 1. Provide technical expertise to production teams, resolving issues as they arise and collaborating closely with Engineering and other support functions.
2. Support daily production operations within the manufacturing area and serve as the first responder for equipment malfunctions.
3. Partner with Facilities Department to maintain appropriate inventory levels of critical spare components and develop/update preventive maintenance (PM) instructions for production equipment.
4. Assist in coordinating and executing calibration and preventive maintenance activities.
5. Complete all required documentation including work orders and GMP records accurately, clearly, and on time.
6. Troubleshoot equipment issues, working with equipment owners, engineers, and external vendors to drive timely resolution.
7. Proactively engage with support teams to develop solutions for recurring or emerging equipment challenges.
8. Foster strong working relationships within the Facilities team and with internal and external customer departments.
9. Collaborate with Manufacturing, Operations, Environmental Health & Safety, and other cross-functional groups to meet production goals.
10. Support onboarding and technical training of Manufacturing personnel on process equipment.
11. Assist MST team with new product introductions and technology transfer activities.
12. Support the revision and management of manufacturing documents such as Batch Records and SOPs.
13. Adapt quickly to changes in production schedules and reprioritize tasks to minimize operational disruptions.
Participate in periodic on-call rotations to monitor and respond to equipment issues.
Qualifications1. High school diploma with at least six (6) years of experience performing maintenance on manufacturing equipment, or an associate's degree or higher in Pharmaceutical Sciences, Engineering, or a related field (preferred).
2. Experience working in sterile fill and finish manufacturing environments.
3. Strong understanding of GMP standards, regulatory requirements, and industry best practices.
4. Ability to work independently while following established procedures, guidelines, and operational practices.
5. Background in continuous process improvement.
6. Strong communication and collaboration skills, with a commitment to maintaining high-quality standards.
Preferred Qualifications1. Understanding of high-speed aseptic filling operations and isolator barrier system technologies.
2. Experience working with single-use components used in drug product formulation, sterile filtration, and aseptic filling processes.
3. Proficiency in Microsoft Office Suite.
Proficiency with Computerized Maintenance Management Systems (CMMS).
Physical Requirements1. The employee is regularly required to speak or hear.
2. The employee must frequently use their hands or fingers to handle, feel, or control objects, tools, or controls
3. The employee is occasionally required to stand, walk, sit, and reach with hands and arms.
4. The employee must occasionally lift and/or move up to 50 pounds.
5. The noise level in the work environment is usually low to moderate.
6. Require extended computer use and data analysis
7. Must complete required onboarding training, including:
- Company policies and procedures.
- Data integrity and confidentiality expectations.
- Safety and environmental awareness (as applicable).
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
WORK ENVIRONMENTAfton Scientific is a mission-driven organization that manufactures life-saving injectable pharmaceuticals. Our culture is collaborative, fast-paced, and quality-focused. As a small company (~100 employees currently, growing significantly), team members at every level have direct visibility to leadership and meaningful impact on outcomes. This is not a back-office accounting role-you will be embedded in a working finance team that directly supports a growing pharmaceutical manufacturer, with exposure to every facet of the business from manufacturing operations to client contracts to capital projects.
