21 Aug
|
CSL
|
Broadmeadows
The Prospect
This Senior Value Stream Recipe Owner is responsible for the ownership, implementation, maintenance, and continuous improvement of PCS/MES, DCS, and PLC process recipes and configurations within a specific manufacturing value stream. The position ensures alignment with global execution system strategies and standards, acts as the technical subject matter expert for execution systems across CAPEX and OPEX projects, and oversees system design, integration, commissioning, validation, and contractor deliverables. The role provides ongoing operational support, including incident management and 24/7/on-call manufacturing support to maximize facility uptime, while coordinating hardware, software, and system interfaces with key platforms such as data historians, building management systems, alarm management systems, manufacturing networks, and enterprise applications. Additionally, the position drives process improvements, system modifications, and compliance with GAMP 5 requirements to support reliable and efficient manufacturing operations.
The Role
- Lead and coordinate execution system recipe delivery across multiple work packages, ensuring technical priorities are aligned and project milestones are achieved on schedule in partnership with Project Managers.
- Own the recipe design and implementation strategy, ensuring manufacturing and engineering requirements are met while adhering to established standards, libraries, and ISA-S88/S95 methodologies.
- Manage the full execution system lifecycle, including requirements definition, detailed design, software configuration, system integration, commissioning, qualification, validation, start-up, and operational support.
- Maintain deep understanding of manufacturing processes within the assigned value stream, collaborating with global and site stakeholders to ensure solutions meet operational needs.
- Develop, review, and maintain technical documentation, software configurations,
validation protocols, test cases, and qualification activities, including troubleshooting and issue resolution.
- Drive quality, compliance, and validation activities, including execution system validation strategy, audit readiness, investigations, CAPAs, change management, and adherence to QMS and global engineering standards.
- Collaborate across multidisciplinary teams and customer groups, including Quality, Engineering, Manufacturing, Facilities, EHS&S;, and CSV, to ensure coordinated delivery, stakeholder alignment, and effective expectation management.
- Identify and implement continuous improvement opportunities within execution systems, optimizing design, programming, testing, and project delivery while supporting workload balancing and, when required, performing interim Project Manager responsibilities.
Required Skills and Experience
- Bachelor's degree in Engineering, Computer Science, Management Information Systems, or a related scientific discipline; Master's degree preferred.
- Minimum 5 years' experience within the pharmaceutical or biopharmaceutical industry, including expertise in Manufacturing, Engineering, Automation, or Execution Systems, with proven experience supporting and delivering automation solutions.
- Strong knowledge of process automation, Manufacturing Execution Systems (MES), and batch manufacturing standards, including ISA-88 and ISA-95 frameworks.
- Hands-on experience in recipe and workflow authoring, along with MES master data, equipment configuration, and manufacturing process implementation across areas such as fractionation, manufacturing, and packaging.
- Demonstrated experience designing, deploying, validating, and supporting automation and execution systems within large-scale, regulated manufacturing environments.
- Experience supporting global shop-floor execution systems is highly desirable, with exposure to Process Excellence or continuous improvement methodologies viewed as an advantage.
📌 Automation Engineer (Broadmeadows)
🏢 CSL
📍 Broadmeadows