This person is responsible for leading successful technology transfer activities at site level, including manufacturing readiness and capacity scale-up.
Oversees and coordinates technical transfer projects at site and liaises with key stakeholders (e.g. R&D, Manufacturing, Quality, HSE, Facilities Engineering Procurement, other surgical sites, Third Parties (Vendors, Mergers & Acquisitions)). Plans, designs, coordinates validation and implementation of high technology equipment and/or processes for the production, finishing and inspection of IOLs and / or other Eye Care Products.
Major Accountabilities 1. Program & Project Management; Responsible for project management of Technology transfer (Product & Process) projects into the Cork plant. This includes planning and liaising with other departments/plants affected by these projects. Also for reporting project status to management and highlighting areas of concern early
Responsible for ensuring all projects are completed to the required technology transfer standards, agreed timelines and within budget. Also that all work adheres to H&S and environmental requirements
Responsible for planning and managing projects to ensure effective utilization of re-sources and for leasing with R&D and other Alcon facilities to develop and introduce new products and processes
2. Technology Transfer Works seamlessly with the Site Validation Lead, Product Steward,, Process Lead and other functional departments on technology transfer projects into the Cork plant Manages technical activities at a site level for product transfers (process, technology, analytics, capacity, resources). Provides technical expertise together with site experts. Defines and monitors project scope, timing and progress. Manages technology transfers for scale-up, at site level.
3.Validation Responsible for liaising with the site Validation Lead and QA for the introduction and validation of new equipment and/or new process projects from design through completion and in compliance with regulatory requirements
4.Continuous Improvement Supports continuous process and quality improvements and ensures that design for manufacturability, efficient processes and a Right First time approach is inherent in the technology transfer process.
5.Compliance/Change Control Responsible for putting effective CAPAs in place for compliance actions related to Technology Transfer within the agreed timeline.
Approval of process / product change control, validation and engineering change orders.
Oversees and contributes where necessary to Manufacturing Process Transfer Documents (MPTP, TDP protocol, report, etc.).
Ensures that all activities are performed to current standards (QM 5.1 Technology Transfer and Corp current Good Manufacturing Practices cGMP, Health Safety & Environmental, Regulatory etc.).
Ensures continual Quality System compliance by adherence to established and evolving Alcon and Novartis QS requirements.
Key Performance Indicators •Technical transfer milestones achieved in time and in full. Including schedule for registration and launches. •Robust manufacturing process, delivering critical quality attributes and capable processes. •No critical observations during internal and external GMP inspections and Pre-Approval Inspections (PAI). •Adheres to project / Capital Approval Request CAR costs.
Impact on the Organisation: High business impact: delays in launch or transfer and critical deviations during external inspections have a significant impact on market shares.
Specific Position Knowledge/Skills/Abilities: •Detailed knowledge of Technology Transfer Standards and best practices •Knowledge of process engineering and equipment and automation specification and GMP validation requirements. •Knowledge of statistical process control and data analysis by statistical methods. •PC and software proficiency •Report writing expertise and highly developed people skills. •Knowledge and/or experience of Product and Process engineering, machine and automation design. •Knowledge and/or experience of optics and optical metrology •Knowledge of requirements of machinery directive - i.e. CE marking •Knowledge of process analysis and optimisation, and basic industrial engineering. •Excellent attention to detail •Highly developed communication skill - oral, written and presentation •Excellent organisation skills •Role model for Novartis Values & Behaviours •Ability to interpret financial and sales reports Minimum requirements Education Minimum: Bachelor degree in Engineering/ Science/Technology or related discipline Preferred: Masters degree in. Engineering/ Science/Technology or related discipline
Experience Minimum: 7+ years' experience in high volume manufacturing environment with at least +2 years' experience of process engineering and process/product technology transfer or New Product Introduction (NPI)
Preferred: 10+ years' experience in high volume medical device manufacturing with at least +5 years' experience of process engineering and process/product technology transfer or New Product Introduction (NPI) Experience to include cross site projects and R&D liaison. Project management and team leadership experience. Regulated industry experience. Demonstrated ability to remain up to date with developing and emerging technologies through the establishment of good working relationships and networks within industry and academia.