Automation Engineer

Position Summary

Process Automation Engineer

biopharmaceutical process design and/or manufacturing

hands-on expertise in automation systems

Upstream operations

Downstream operations

Functional Responsibilities

• Design, develop, and implement automation solutions for Upstream and downstream operations
• Develop process control strategies in compliance with ISA S88 standards for batch process automation
• Create, configure, and validate recipe management systems for complex biopharma operations
• Design and implement PLC-based control systems using platforms such as Siemens WinCC, PCS7, or similar
• Configure and maintain DCS platforms, including Siemens PCS7 and/or DeltaV from Emerson
• Collaborate with cross-functional teams including process engineering, validation, manufacturing, and quality
• Troubleshoot and resolve automation-related issues during project execution or manufacturing daily operations
• Author and review automation documentation including design specifications, FRS,SDS, HDS, URS, FAT, SAT, and validation protocols
• Implementing minor and major expansion projects on site and changes targeting optimisation as part of the operational support
  

Primary Responsibilities

• Project Ownership: Accountable for the successful execution of projects from initiation through completion, ensuring all deliverables meet client expectations and regulatory standards.
• Quality Assurance: Responsible for ensuring that all processes comply with cGMP and other regulatory requirements, thereby safeguarding product quality and patient safety.
• Client Satisfaction: Ensure high levels of client satisfaction through effective communication, timely updates, and proactive problem-solving.
• Compliance and Risk Management: Identify and mitigate risks associated with technology transfer, ensuring that all operations are compliant with internal and external guidelines.
• Develop and validate process maps and models in collaboration with cross-functional teams.
• Adapt to additional tasks and responsibilities as assigned, demonstrating flexibility and a proactive approach.
  

Education

• B.Tech/M.Tech in Industrial Process Engineering, Automation Engineering, Instrumentation & Electrical Engineering, Chemical Engineering or related fields.
• 7-10 years of relevant industry experience in biopharmaceutical automation (process design, commissioning, or manufacturing support)
• In-depth knowledge of biotech manufacturing processes, with specialization in Upstream automation, not limited to process including software writing and IT & infrastructure
• Experience with PLC and SCADA/DCS platforms: Siemens WinCC, PCS7, DeltaV, or comparable systems
• Proficient in batch process control, recipe creation as per ISA/S88 is a must
• Strong understanding of instrumentation, P&IDs, control strategies, and process control hardware/software integration
• Knowledge of GAMP5, 21 CFR Part 11 compliance, and other regulatory guidelines
• Hands-on experience in project executions including qualification phase (IQ/OQ/PQ) and on-floor operations
• Excellent communication and documentation skills
  

Preferred Attributes

• Experience with single-use technologies (SUT) and Stainless-Steel technologies in bioprocessing
• Prior involvement in facility design or greenfield/brownfield projects
• Experience working with digital plant systems or in digital transformation initiatives in biopharma
• Exposure to data historians, automation analytics, and real-time monitoring systems