If you’re passionate about turning complex requirements into elegant, validated systems—and you thrive in a collaborative, matrixed environment—this role is your opportunity to make a visible impact on tech transfer timelines, batch right‑first‑time performance, and regulatory readiness. | Why you’ll love it here | - Shape how development knowledge (DoE, QbD) flows into manufacturing execution and CPV | - Own high‑value platforms with direct line of sight to business outcomes | - Partner across PD, MSAT, Automation/Engineering, QA/Validation, and IT/OT | - Drive standardization at scale with class‑based, globally reusable configurations | - Operate with autonomy while influencing best practices across sites | What you’ll do | - Design, configure, implement, and maintain PDLM, ELN, and Risk Management platforms to meet user and compliance requirements | - Translate business needs into scalable, class‑based configurations and reusable library objects that enable data standardization | - Ensure cGxP, data integrity (ALCOA+), and data security across integrations; partner with QA/CSV on risk‑based validation (GAMP 5, CSA) and audit readiness | - Define and enforce standards, templates, libraries, and master data structures in partnership with Master Data teams | - Deploy class‑based data structures to deliver recipe data models and master data (materials, specs, equipment classes) | - Develop training, job aids, and adoption materials; coach teams on ISA‑88 and digital recipe best practices | - Manage external partners and solution vendors; define user requirements, participate in design reviews, and ensure delivery to standards and timelines | - Contribute to digital thread initiatives linking development knowledge to manufacturing execution and CPV; support regulatory inspections and filings | - Drive harmonization and standard work across sites (templates, test protocols, UAT scripts) to reduce cycle times and deviations | - Champion continuous improvement through metrics, KPIs, and standardized ways of working | What success looks like | - Seamless, compliant platforms that accelerate development and tech transfer | - Standardized data models and libraries that scale globally | - Strong adoption and user satisfaction through clear training and enablement | - Audit‑ready documentation and validated configurations | - Reduced cycle times, deviations, and rework through harmonized processes
- Consult with FLBK staff about site facilities and amenities to define and direct work. | - Oversight of outsourced Facilities Management contract. | - Manage and maintain the site inventory for building leases. | - Assist the capital project team in providing major new buildings or improving existing facilities at FLBK. | - Manage the safe system of work for maintenance and improvement activities within non-process areas. | - Monitor utility consumption. | - Responsible for site security and deliver site metrics for physical asset performance.
The primary purpose of this role is to support and maintain site Automation systems, ensuring ongoing system availability and maximising uptime. The role holder will act in the capacity of Automation SME to support Process Owners in their delivery of business objectives and manufacturing plans – this shall include fault-finding and issue resolution. The role holder will act as Automation SME to CAPEX project teams as required, supporting delivery of small to medium sized projects including system upgrades and new deployments. The role holder will deliver small projects and continuous improvement activities for Automation systems, including Qualification/Validation deliverables. | | The role holder shall be expert in software design, development and hardware integration using the DeltaV control platform. Experience with DeltaV batch configuration is essential. Experience in configuration using DeltaV Live is desirable. Experience in configuration and administration of AVEVA PI systems is highly desirable. Experience in in configuration of batch reports using the Informetric InfoBatch application is desirable. Significant experience operating in a cGMP environment is essential. | | | Principal Accountabilities | | - Act as SME working to deploy and maintain site Automation systems. Provide expertise in the following areas: | | - | - Field Instrumentation | - Microprocessor and computer system-based controllers | - SCADA | - PLC & HMI | - DCS | - Control networks | - Process data capture and integration to third-party systems for data capture and control | | | - Responsible for adherence to and promotion of the highest standards of professionalism and compliance to corporate standards in Quality, Environmental, Safety, Engineering, Financial and Ethical practises through the company tiered accountability processes and procedures. | - Manage the preparation, review and submission of outline Automation technical proposals, cost and scope estimates and resource and cost plans to meet requests from production, engineering and business customers for work on process control systems. | - Contribute as an Automation SME to CAPEX and Revenue forecasts supporting site Operating and Maintenance and Capital expenditure planning. | - Contribute to and support maintenance of Automation best-practise standards, including Operating Procedures and technical standards/guidance. | - Deliver Qualification/Validation scope for small projects and continuous improvement activities (Change Controls). Own and progress Change Controls concerning control systems as necessary. | - Support achievement and maintenance of Validated status of GMP-impacting systems by creating/updating lifecycle documentation as required, to include System SOPs, Periodic Reviews and Maintenance Plans. | - Provide system support to Process Owners as necessary, including fault-finding and issue resolution. Support and own quality records, to include Deviations, CAPAs and Effectiveness Checks, as required. | - Sound knowledge of OT architecture and integration and communication protocols, including OPC, MODBUS, Profibus/Profinet, Fieldbus.