Key Responsibilities
DeltaV System Design & Implementation
- Design & Deliver DeltaV Systems: Lead the design and implementation of DeltaV application systems for the site, ensuring alignment with project requirements and GMP standards.
- S88 Standards Compliance: Develop and implement automation solutions in compliance with ISA S88 standards, including control modules, equipment modules, phases, recipes, and units.
- System Architecture & Controls Strategy: Collaborate with the development team to define system architecture, specifications, controlstrategies, and sequence of operations, ensuring all stages are accounted for in the design and development plan.
Commissioning & Qualification (C&Q)
- C&Q Protocol Development: Develop commissioning and qualification protocols based on C&Q plans, ensuring alignment with GMP regulations.
- System Testing & FAT: Supervise and execute Factory Acceptance Testing (FAT) to ensure system functionality and regulatory compliance.
System Development Life Cycle (SDLC)
- SDLC Deliverables: Create, review, and maintain SDLC documentation in accordance with site standards, ensuring that all deliverables meet quality and compliance requirements.
- Data Flow & Process Design: Define and document processes and data flow that support project needs, optimizing system performance and compliance.
Automation Strategy Compliance
- Automation Strategy: Ensure that the project’s automation strategy is followed, guaranteeing a streamlined approach to system development and integration.
Requirements
- Industry Experience: Experience in a similar role, ideally in pharmaceutical and/or biotechnology industries, with a focus on automation solutions for GMP manufacturing.
- DeltaV Expertise: Proficiency in Emerson DeltaV DCS, with extensive experience in DeltaV Batch systems, including commissioning, qualification, and design.
- Technical Proficiency: Strong technical skills in control systems, including control panels, networking, PLC systems, panel/field wiring, and system integration.
- Batch S88 Standards: In-depth understanding of Batch S88 standards, including control modules, equipment modules, phases, recipes, and units.
- GAMP & Quality Management: Familiarity with GAMP lifecycle standards and quality management processes commonly used in the pharmaceutical industry.
- Teamwork & Collaboration: Ability to work effectively within a team, collaborating with cross-functional teams to achieve project goals.
- Testing & Troubleshooting: Experience conducting system testing, particularly Factory Acceptance Testing (FAT), and resolving technical issues.
- Software Proficiency: Advanced skills in Microsoft tools (Excel, SharePoint, Word, and PowerPoint).
- Communication Skills: Strong communication and customer orientation skills, with the ability to explain technical details clearly.
- Problem-Solving Skills: Excellent analytical and problem-solving abilities to address challenges during project execution.
