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Process Automation Specialist
2 weeks ago
Job Title: Process Automation Specialist
Job Summary:
We are seeking a skilled and motivated automation specialist to lead process automation projects in the biopharmaceutical industry.
The ideal candidate will bring hands-on experience in automation systems, particularly within Upstream operations and add on experience in Downstream operations (chromatography, ultrafiltration/diafiltration, nanofiltration).
This role offers the opportunity to work on cutting-edge projects in process automation, recipe management, and control system design using advanced platforms and extend to digital transformation initiatives.
Key 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.
Requirements:
- Bachelor's/Master's degree 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
