Manager OT Systems and Automation Specialist

1 maand geleden

Leiden, Zuid-Holland, Nederland Bristol Myers Squibb Voltijd
Job Summary

The Manager, OT Systems & Automation – Cell Therapy Manufacturing Systems, will play a critical role in the successful implementation and operation of Process Automation systems (PAS) through collaboration with internal team members, peer and higher-level customers, as well as external service providers. This individual will be responsible for developing and adhering to system governance procedures.

Key Responsibilities
  • Work as a subject matter expert (SME) on the Leiden Cell Therapy Process Automation System (PAS) - DeltaV, contributing to its development and operation.
  • Act as the main point of contact during Project delivery and Operational support for DeltaV system, including DeltaV Database management and technical support, DeltaV software Configuration, DeltaV Batch Automation, DeltaV Recipe management (changes and issue resolution), interfaces with DeltaV such as MES and OsiPi.
  • Work as SME on DeltaV batch configuration (S88), Unit Operations/recipe/phase logic programming, troubleshooting software issues and updates, DeltaV Graphics Live issues, and updates for continuous improvement.
  • Participate in on-call support (outside normal office hours) during operations as second-line support (L2) in resolution and support to manufacturing shopfloor issues related to DeltaV.
  • Participate in continuous improvement initiatives, contributing to RCAs, CAPAs, Change Controls, and SNOW (Service Now) for DeltaV process automation.
  • Collaborate with global Automation SMEs for standardization initiatives at Leiden CTF.
  • Help set the DeltaV priorities for the Leiden CTF and work on the delivery of these priorities.
  • Work with technical teams to develop requirements, code, and test deliverables and drive execution of system testing at the site level.
  • Network and work with other cell therapy DeltaV members to proactively identify issues with cell therapy-based requirements and drive resolutions.
  • Work with enterprise DeltaV team and SMEs to develop DeltaV standards, philosophy, design approach, and SOPs for Leiden CTF.
  • Drive and support the resolution of critical DeltaV issues during Project delivery as well as during Operations.
  • Support Sr. Manager OT and Automation during internal and external Audits for process automation system (DeltaV).
  • Support Sr. Manager OT and Automation in ensuring GxP and GAMP requirements are followed for process automation system.
  • Support and Partnering with Manufacturing Ops, MS&T, Quality, Site Engineering as Automation & OT partner for continuous improvement of Automation & OT systems primarily DeltaV, OsiPi, and BAS.
Requirements
  • Bachelor's degree in an engineering, IT, or Science field or equivalent experience.
  • Extensive hands-on experience with Emerson DeltaV, especially DeltaV configuration, software database configuration, and DeltaV batch automation.
  • Able to configure DeltaV database, experience with writing and debugging unit operations, unit recipes, and unit phase logic.
  • Experienced in commissioning of DeltaV system, including changes to DeltaV software (unit operations, phases, unit phases, classes, instances, etc.).
  • Experience with DeltaV Graphics Live.
  • Understanding of S88, S95, and DeltaV batch processing operations required.
  • Minimum 5+ years of relevant industry experience, preferably GMP as DeltaV specialist.
  • Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
  • Understanding of engineering documentation such as P&IDs, process flow diagrams, and standard operating procedures.
  • Ability to troubleshoot DeltaV control system from the field element up through operator interfaces and databases.
  • Knowledge of HCI or Dell VTRX DeltaV infrastructure and VMs.
  • Knowledge of DeltaV PK controllers, VIM cards, Emerson smart switches.
  • Biologics/Cell Therapy experience is highly valued but not required.
  • Knowledge of DeltaV.
  • Knowledge of Osi Pi is highly valued but not required (willing to learn).
  • Knowledge of BAS (Honeywell) is highly valued but not required (willing to learn).
  • Integration experience with MES is highly valued but not required.
  • Experience working with SQL, Server, Oracle, SAP, or other relational databases preferred but not required.

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