Role: Technical Project Manager
Location: Framingham, MA
Duration: Full Time
First 3 months need to work from client place after they can work remotely and travel based on the need.
· Experience in Green field MES deployment Project management.
· Experience in various Bio-Pharma business processes like Harvest/ Depth Feed and Filtration Prep, Chromatography, API - Refiltration, Solution Preparation, Filter Assembly, Column Packing etc.
· Experience in Werum PAS-x (v 3.1.8) MES system functionalities (W&D, Equipment Management, CX Definition, Material Master etc.).
· Experience in MBR/(G)MBR/ ESP / Master data designing, configuration and testing.
· Experience in MES integration with Printers, Scanners, Scales, SAP, WMS and Automation layer.
· Knowledge of various validation documentation requirement.
· Experience in supporting SIT/UAT execution to Client team.
· Experience in Automation systems (DCS, OSI PI, Historian etc.)
· Experience of creation documentation like URS, Tractability matrix, Functional risk assessment, Validation plan, validation report, IQ, SIT, UAT test scripts, User training material creation,business SoP creation
· Single point of contact to Client for MES deployment project.
· MES Project Plan preparation with input from related project plans for facility and equipment installation and commissioning, technology transfer for Manufacturing Process.
· Accountable and responsible for tracking the execution and deliverables for MES deployment project (MBR creation, testing and validation documentation deliverables).
· Collaborate among MES deployment team (On-site & Off-Shore), Client team and other third party to manage dependency, resolve issue and avoid risk to achieve agreed schedule and quality of deliverables.
· Manage stakeholder' requirement and communication, and periodic status reporting.
· Liaise regularly with Client IT-PM in regards to the activities at the site and any eventual critical issue related to the MES System and the overall project execution, and mange timely escalation.
· Manage and monitor regular project execution activities and deliverables of the project team.
· Perform Gap analysis of Client's existing Core MES solution to new MES business requirements and Propose Mitigation.
· Assist MBR, (G)MBR, ESP, Master data creation and performing dry runs.
· Prepare overall test plan
· Manage and support MES System training (Operator, MBR Designer, GMP Officer, Supervisor) to key users, SoP creation.
· Assist UAT execution and Support GO-LIVE activities.
· Manage and assist during post go-live activities (Engineering shakedown, PV runs)
· Manage Hypercare and handover of the system to the Client support team at the end of the hyper care period.