Deltav Batch Engineer
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Requirements
- Min. 3 years experience in DeltaV System, DeltaV Batch Software Design and Configuration.
- Degree in Chemical/Electrical Engineering, Computing or IT
- Excellent problem-solving ability and customer-focused
- Strong technical writing and documentation skills are required
- Must be proactive, have experience with high performance teams
- Good teamwork and communication skills; ability to interact across functional teams at multiple levels within the organization
- Good skills in Windows operating system administration, programmable logic controllers, Visual Basic programming, databases and general programming would be added advantage
- Technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems.
- Have trouble shooting capabilities. Be able to use engineering thinking and principles to tackle complex technical/process issues.
- Have working knowledge of FDA Regulations/Guidance, and Good Manufacturing Practices
Additional Information
Design and implement process automation systems and solutions to manage a batch pharmaceutical manufacturing environment Hands on experience performing DeltaV Batch configuration Manage software development projects from design to implementation for new automation configuration/data collection systems and expansion to existing systems Support in system FAT and SAT Support troubleshooting and investigation of production process, equipment, systems and code/configuration related to quality or safety issues. Implement the relevant improvement solutions On-Call support for Biologics Manufacturing and API plants, Improvements/troubleshooting of existent Control Strategies, Project progressing according to plan and quality expectations Commissioning and qualification activities for new logic implementation Develop Functional Specifications (FS) and Design Specifications (DS) in alignment with Client's site requirements. Review PCS-related design documentation and provide feedback to ensure compliance with user requirements and approved standards. Track project deliverables, maintain documentation, and ensure adherence to the agreed schedule. Batch software commissioning and functional testing Qualification testing, including Installation Qualification (IQ) and Operational Qualification (OQ) Support Engineering and Performance Process Qualification (PPQ) batches as required. Support and track change management processes throughout the project lifecycle.
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