Automation Engineer Job Charlottesville area,Virginia USA,Engineering

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

FDAandEMAguidelines, 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

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

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

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

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

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

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

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

Participate in audits and inspections, ensuring readiness and compliance.

Support continuous improvement initiatives and process optimization.

Manage external vendors and system integrators when applicable.

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

Qualifications

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

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

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

Experience with SCADA/DCS systems (e.g., Wonderware , Delta

V )

Strong knowledge of GMP environments and validation processes

Familiarity with data integrity and computerized system validation (CSV)

Excellent troubleshooting and problem‑solving skills

Experience working in sterile fill and finish manufacturing environments.

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

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

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

Preferred Qualifications

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

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

Proficiency in Microsoft Office Suite.

Proficiency with Computerized Maintenance Management Systems (CMMS).

Physical Requirements

The employee is regularly required to speak or hear.

The employee must frequently…