Automation Engineer in Charlottesville, Virginia at Afton Scientific. LLC

COMPANY OVERVIEW

Afton Scientific is a privately held, PE-backed sterile fill-finish contract development and manufacturing organization (CDMO) headquartered in Charlottesville, Virginia. For over 20 years, Afton has provided aseptic manufacturing services for biologics and small-molecule injectables, supporting clients from clinical trials through commercial supply. The company operates FDA-inspected, cGMP-compliant manufacturing facilities and is currently executing a $200M+ expansion (Avon IV) that will add high-speed isolator-based filling lines and significantly increase capacity.

Afton serves pharmaceutical and biotech companies across oncology, metabolic/obesity therapeutics, immunology, infectious disease, and rare disease markets. Our location in central Virginia places us within a one-day drive of approximately 50% of the U.S. population, a strategic advantage for cold-chain and time-sensitive pharmaceutical logistics.

The Automation Engineer is responsible for designing, implementing, maintaining, and optimizing automated systems supporting pharmaceutical manufacturing processes. This role ensures systems operate in compliance with regulatory requirements including FDA and EMA guidelines, with a strong focus on reliability, data integrity, and product quality. The role calls for strong critical thinking and the ability to assess business implications before taking action, helping to avoid unintended consequences such as safety issues, equipment downtime, or other operational risks. It also requires sound independent judgment and the resilience to excel in a fast‑moving, small‑company environment where priorities shift quickly. The ideal candidate brings a proven track record of delivering results in a high‑paced sterile manufacturing setting, while demonstrating professionalism, collaboration, and adaptability in a high‑performing team culture.

Key Responsibilities

1. Design, develop, and maintain automation systems (PLC, SCADA, DCS) for manufacturing and packaging operations

2. Support commissioning, qualification, and validation activities (IQ/OQ/PQ) for automated equipment.

3. Ensure compliance with 21 CFR Part 11 and GAMP 5 standards.

4. Troubleshoot and resolve automation and control system issues to minimize downtime.

5. Develop and update control strategies, HMI interfaces, and batch recipes.

6. Collaborate with cross-functional teams including Quality, Validation, and Manufacturing.

7. Maintain accurate documentation including SOPs, change controls, and technical specifications.

8. Participate in audits and inspections, ensuring readiness and compliance.

9. Support continuous improvement initiatives and process optimization.

10. Manage external vendors and system integrators when applicable.

11. Responsibilities may change based on business needs and intern development opportunities.

Qualifications

1. Bachelor’s degree in Electrical Engineering, Chemical Engineering, Automation Engineering, or related field.

2. 3–7+ years of experience in automation within the pharmaceutical or regulated manufacturing industry

3. Hands-on experience with PLC platforms (e.g., Siemens, Rockwell Automation)

4. Experience with SCADA/DCS systems (e.g., Wonderware, DeltaV)

5. Strong knowledge of GMP environments and validation processes

6. Familiarity with data integrity and computerized system validation (CSV)

7. Excellent troubleshooting and problem-solving skills

8. Experience working in sterile fill and finish manufacturing environments.

9. Strong understanding of GMP standards, regulatory requirements, and industry best practices.

10. Ability to work independently while following established procedures, guidelines, and operational practices.

11. Strong communication and collaboration skills, with a commitment to maintaining high‑quality standards.

Preferred Qualifications

1. 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.

4. Proficiency with Computerized Maintenance Management Systems (CMMS).

5. Project management experience

Physical Requirements

1. 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 ENVIRONMENT

Afton 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.