Automation Engineer

Automation Engineer

Role Overview:

This includes support for manufacturing operations, new technology introduction, troubleshooting, and lifecycle management.

Key Responsibilities:

• Administer and monitor automation systems (PLC, SCADA, PCS, BMS).
• Ensure compliance with GMP, EHS, and quality standards.
• Perform root cause analysis, lead investigations, and implement improvements.
• Conduct change control and lifecycle activities (backups, updates, periodic reviews).

• Support hardware/software upgrades and system integration.
• Manage small/medium automation projects through full life cycle.
• Participate in commissioning and qualification activities.
• Lead continuous improvement initiatives.

• Disaster recovery, configuration, access management.
• Validate systems per CSV and GAMP standards.
• Optimize maintenance plans using FMEA and performance data.

• Document deviations, complete CAPAs and quality records.
• Maintain compliance with 21 CFR Part 11, EU Annex 11, and site policies.

• Ensure contractor compliance, safe work environments, and timely reporting of incidents.
• Adhere to PPE and participate in EHS programs and training.

Qualifications & Experience:

Ideal Candidate:

• Degree in Automation, Electrical, Chemical, Computer Science, or Biotech Engineering.
• 5+ years' experience in biopharma manufacturing automation (API or Fill/Finish).
• Strong knowledge of PLC (Siemens, Allen Bradley), PCS7, SCADA, BMS, and batch systems.
• Experience with industrial networks (ControlNet, Profibus), OSIsoft PI, VersionDog, etc.
• Familiar with GAMP5, S88/S95, 21 CFR Part 11, and Annex 11.
• Demonstrated experience with technical writing, project execution, and regulatory audits.

Minimum Requirements:

• Bachelor's degree in relevant field.
• 2+ years hands-on automation experience in a cGMP environment.
• Experience in Siemens PLC/HMI, PCS7, SCADA, and network technologies (TCP/IP, AD).