GMP Automation

Job Summary:
Own and maintain building management and environmental monitoring systems for a new manufacturing facility. Partner with engineering, quality, and manufacturing teams to design, install, and continuously improve automation systems that support quality, compliance, and efficient production.

Required Qualifications:
- Own and maintain building management and environmental monitoring systems
- Design, configure, install, and maintain automation software and associated hardware across GMP and non-GMP systems
- Lead integration of third-party equipment into plant automation and distributed control systems
- Prepare scopes of work and manage automation contractors
- Develop project objectives aligned with user requirements and operational priorities
- Author and maintain system documentation (user requirements, functional specifications)
- Ensure automation systems meet GMP, regulatory, and internal compliance requirements
- Partner with Quality to support an inspection-ready manufacturing environment
- Troubleshoot automation issues impacting operations
- Execute change controls and support investigations related to automation non-conformances

Essential Requirements:
- Bachelor’s degree in Engineering, Computer Science, or related technical discipline
- 5+ years’ experience supporting GMP automation in pharma/biopharma manufacturing
- Hands-on experience with Distributed Control Systems (Emerson DeltaV)
- SCADA/HMI experience (Copadata enon, Rockwell FactoryTalk)
- PLC/building systems experience (Emerson PACSystems; Allen Bradley CompactLogix/ControlLogix)
- Data historian/OSISoft PI; basic SQL development
- Knowledge of system validation and change control in regulated environments
- Strong communication and cross-functional collaboration