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Zenith Technologies, now a Cognizant Company is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies, whilst maintaining compliance. Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services. Operating across 5 continents and with over 850 skilled employees, Zenith partners with the leading Life Sciences companies globally to provide performance improvements, reduced costs and improve time to market.
We are seeking an experienced Project Manager to provide Project Management support in relation to the deployment of Manufacturing Systems (MES, Historian, LIMS, Network, & Level 2-4 integration) for ongoing IT/OT projects at our client’s site in Dublin.
* Detailed Ongoing Project Planning
* Detailed Schedule Management
* Action assignment and monitoring to team members
* Team meeting hosting / attendance / chairing / minutes
* Team Matrix Management (Coordination, Coaching 1:1, Timesheet review & signoff)
* Solution scope, requirements & design support
* Quality/Validation strategy (CSR) steering / oversight
* Ensure high document deliverable standards, including Team and Vendors
* Solution risk management
* Business Stakeholder relationship building & alignment
* Proactive and progressive issue escalation (people, solution, schedule/project)
* Routine proactive reporting to Program Manager and Stakeholders as required
* In addition to the above, other Project Management responsibilities commensurate with the experience and skills of the successful candidate may be assigned.
Desired Experience / Skills / Attributes
a. The following application knowledge required, listed in order of priority…
* PAS-X MES V3.1.7 W&D, MBR’s, and Master Data configuration
* OSI-PI Historian tag integration, Asset Framework, and Event Frames
* Labware LIMS V6-7 Methods, Environmental Monitoring, Equipment Integration, and broad system functionality
* Integration from shop floor equipment to OSI-PI and OSI-PI to PAS-X aligned with ISA S-95 principles
* Integration between MES and SAP for master data, production dispatch, and production execution
* IT/OT network topologies and components
b. While hands on configuration of the systems above is not required, an understanding of system functionality and business requirements is required to ensure oversight of system status. This knowledge is also required to support a timely analytical approach to problem solving for escalated issues and routine issue reporting.
c. A basic understanding of IT infrastructure is required including relational databases (Oracle), server/network architecture, and deployment methods for Level 3 Manufacturing Systems (e.g. barcode scanners, printers, specialist HMI’s, and mobile devices).
d. An excellent project lifecycle skillset is required through requirements, specification, configuration, verification, and handover to business/quality users. Throughout the life cycle, team engagement, verbal communication, functional requirements & design documentation, validation support, and strong interpersonal skills will be required.
e. Understanding of Project Management tools and techniques is required, ideally underpinned by a formal Project Management credential (e.g. PMP, PRINCE2, or equivalent alternative). Example of planning, monitoring, and project control tools include project plans, scheduling, requirements gathering, risk management, status reporting, performance measurement and team matrix management.
a. Experience of delivering projects within the Pharmaceutical sector is mandatory, with emphasis on understanding small molecule API, capsule manufacture, and secondary packaging, plus cell therapy Drug Substance and Drug Product manufacture in Aseptic Environments.
b. A background in GxP environments and practices is required, including knowledge of applicable regulations, guidelines/good practices, and standards.
c. Strong knowledge of GAMP5 good practices and prevailing Data Integrity regulatory guidance is required, especially as applied to Computer Systems Validation and overall compliance.
a. A minimum of 10 years of project management/leadership in Pharmaceuticals, with exposure to the technical and industry skillsets above is required.
b. This is an “embedded” Project Management role reporting to the IT/OT Program Manager. The successful candidate will Manage the project within a core team of 6-12 contract resources (including a Lead Engineer per MES/LIMS/Historian workstream) assigned for the project duration, with support from full time site MES/Automation/Lab Application System Owner representatives and Integrators/Vendors. Collaboration with the broader site team is also critical including IT, Quality, QA Validation, Compliance, Technology Transfer, EHS, & Engineering).
c. Due to the breadth of this role, in addition to the technical aspects, exceptional interpersonal skills are required in terms of verbal engagement style, a calm but assertive temperament, conflict de-escalation, team relationship building, people motivation, and proactive issue reporting and escalation
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