Mantell Associates
Mantell Associates is partnered with a growing and technologically driven drug product CDMO, who is seeking an experienced Senior Automation Engineer to join its engineering team in California.
This pivotal role will design, implement, and optimise automation solutions that enhance manufacturing reliability, compliance, and efficiency.
Senior Automation Engineer – Responsibilities:
- Lead the design, development, implementation, and support of automation systems across drug product manufacturing operations, including PLC/SCADA/DCS, batch control, and automated data capture systems
- Collaborate with Engineering, Manufacturing, Quality, and Validation teams to deliver robust, compliant automation solutions that support production scale-up and GMP manufacturing
- Define automation requirements, develop specifications, perform system configuration, and execute testing (FAT/SAT) in alignment with project timelines and quality expectations
- Troubleshoot automation system issues in manufacturing environments and provide effective, timely resolution while ensuring minimal impact to operations
- Support system validation efforts including URS/SRS development, test plan creation, execution, and documentation to meet regulatory standards (FDA, EMA)
- Contribute to continuous improvement initiatives by identifying automation opportunities, improving process repeatability, enhancing data reliability, and reducing manual effort
- Mentor junior engineers and share automation expertise with cross-functional engineering resources
- Maintain automation systems documentation, control logic libraries, and configuration standards in accordance with GMP and company procedures
Senior Automation Engineer – Requirements:
- Bachelor’s degree in Electrical, Controls, Automation, Mechatronics, or related engineering discipline
- 5+ years’ hands-on experience in automation engineering within a regulated manufacturing environment; CDMO or pharmaceutical experience strongly preferred
- Proven expertise with industrial automation technologies and tools such as PLC (Rockwell/Siemens), SCADA/HMI, batch control systems, DCS, and field instrumentation
- Strong understanding of automation lifecycle: requirements gathering, design, configuration, testing, validation support, and operational hand-off
- Experience supporting automation in GMP environments with familiarity with validation expectations and regulatory compliance
- Excellent problem-solving skills, analytical mindset, and ability to communicate complex technical concepts clearly
- Self-motivated team player with strong organisational skills and ability to lead technical projects
- Based in California, with legal eligibility to work in the U.S. and ability to be on-site as needed
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.