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 my Biotech Client’s manufacturing site. This is an exciting & challenging opportunity for the right candidate to support these projects for new innovative Cell Therapy projects.
The Manufacturing Systems in question will be deployed using existing system installations, solution templates, integration models (to SAP and Shop Floor), and systems procedures, so the focus will be on configuring the existing systems to meet the needs of the new product/intermediate introductions and plant capacity extensions. Hence this is an opportunity for the successful candidate to deliver using their experience and skills, but also to grow and develop their project & technical skillset in collaboration with our team and Vendor consultants.
- Role: P2/P3 Level 3 Systems Technical Project Manager (contract)
- Duration: This is a 12-month contract position starting in June 2021, with potential for contract extension thereafter.
- Location: Billable time will be a combination of off-site and on-site presence. As a guidance, 50% of time may be off site, but this is subject to variation depending on project dynamics, and the candidate must be flexible to be on site by exception at short notice
- 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
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.
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).
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
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.
- 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
- background in GxP environments and practices is required, including knowledge of applicable regulations, guidelines/good practices, and standards.
- 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 minimum of 10 years of project management/leadership in Pharmaceuticals, with exposure to the technical and industry skillsets above is required
- 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).
- 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.
Start Date: July 5th
Duration: 12 months (extension likely)
Interested? Get in touch by emailing your CV to email@example.com and I’ll get in touch ASAP. Interview will happen May 17th.