DELTAV BATCH ENGINEER - Part-Time

• 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.

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
• Skills: Process Automation, System Administration, Test Strategy, Troubleshooting, Virtualisation, Control Systems, Databases, DCS, Documentation Skills, FDA, Liaising with cross functional teams, Management Skills, Manufacturing, on-call support, Pharmaceutical Manufacturing, Project Management, Software Design, Software Development, Technical Writing, Windows