Automation Engineer
2 days ago
About the Role:
We are seeking an Automation Engineer to support automation systems in a GMP-regulated pharmaceutical environment. The role involves designing, implementing, and maintaining process control systems while ensuring compliance with industry standards. Candidates with experience in DeltaV, Siemens, or Siemens PCS7 will be highly preferred.
Key Responsibilities:- Configure, troubleshoot, and optimize automation systems, including DeltaV, Siemens, or Siemens PCS7.
- Support the design, implementation, and validation of automation solutions in pharmaceutical manufacturing.
- Develop and review automation-related documentation, including functional specifications, system architecture, and validation protocols.
- Ensure compliance with GMP, FDA 21 CFR Part 11, GAMP 5, and data integrity regulations.
- Work closely with engineering, manufacturing, and quality teams to support automation integration and process improvements.
- Perform root cause analysis and troubleshooting for automation system failures and implement corrective actions.
- Participate in change control processes, system upgrades, and cybersecurity risk assessments.
- Bachelor's degree in Electrical, Automation, Control Systems Engineering, or a related field.
- 3-5 years of experience in automation engineering within a regulated industry (pharmaceutical, biotech, medical devices).
- Hands-on experience with DeltaV, Siemens, or Siemens PCS7.
- Strong knowledge of GMP, GAMP 5, 21 CFR Part 11, and validation processes.
- Experience with SCADA, PLC, HMI, and batch process automation.
- Ability to develop and execute automation validation protocols (IQ, OQ, PQ).
- Strong problem-solving skills and ability to work independently.
Troubleshooting
FDA
Process Automation
Ability To Work Independently
GMP
GAMP
Root Cause Analysis
Electrical
PLC
Test Automation
SCADA
Medical Devices
Change Control
API
Systems Engineering
Process Control
System Architecture
Manufacturing
Electronics
Commissioning
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