Senior Automation Engineer
About The Position
This is an operational technology (OT) role focused on industrial control systems (PLC/SCADA/HMI) in a pharmaceutical manufacturing environment — not IT, software, or DevOps automation. The role involves coordinating the development, implementation, and support of site automation and SCADA systems, including PLC/HMI, batch, historian, and MES interfaces. Responsibilities include reviewing and approving technical specifications, drawings, and code, leading problem-solving and root cause analysis, training others on systems and procedures, developing and implementing validation protocols, maintaining SOPs, monitoring system performance, and coordinating with third-party suppliers. The position also requires authoring and handling change records, deviations, CAPAs, and investigations, supporting audits, leading capital project execution, evaluating and specifying new automation tools, and maintaining documentation in compliance with GMP, SOPs, and safety requirements. The role promotes a safe work environment, provides on-call support, and ensures work follows established processes. While there are no direct reports, project-based or matrix leadership may be provided.
Requirements
- Bachelor's Degree in Engineering, Computer Science, or related field
- Validated 4 years experience in one of the following: Industrial automation systems in a manufacturing environment, preferably pharmaceutical or regulated industry; OR Pharmaceutical/biologics process engineering or quality engineering with direct teamwork on automation and control systems
- Proven ability to fix or interpret control logic, batch sequences, or PLC programs
- Knowledge of process and utility development, operation and maintenance
- Detailed understanding of GMP related to facility development and operation
- Strong problem-solving skills
Nice To Haves
- Experience with Rockwell Automation control systems
- Experience in automation, SCADA systems, software development
- Comprehensive understanding of IT infrastructure as it relates to automated systems
- Detailed understanding of electrical schematics
- Understanding of instrumentation and maintenance of equipment applied in automated systems
- Lean Leadership principles and application in a GxP environment
Responsibilities
- Coordinate development, implementation, and support of site automation and SCADA systems (PLC/HMI, batch, historian, MES interfaces).
- Review and approve technical specifications, drawings, and code.
- Lead solving, root cause analysis, and corrective actions.
- Train others on systems and procedures.
- Develop and implement validation protocols and maintain SOPs.
- Monitor system performance and identify improvement opportunities.
- Coordinate third‑party suppliers during system development, installation, and qualification.
- Provide on‑call automation support.
- Author and handle change records, deviations, CAPAs, and investigations.
- Support internal/external audits and interactions with regulatory agencies.
- Lead capital project execution within budget and timelines.
- Evaluate and specify new automation tools and equipment.
- Maintain documentation and ensure compliance with GMP, SOPs, and safety requirements.
- Promote a safe work environment and proactively address hazards.
- Provide timely on‑call support and collaborate with maintenance and metrology teams.
- Implement change controls to improve qualified systems.
- Promote cost‑conscious decision‑making.
- Ensure work follows established processes and standard procedures.
- May provide project‑based or matrix leadership.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
