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We are searching for the best talent for Senior Manager, Strategic Projects Operational Readiness MedTech to be in San Jose, Costa Rica.
Purpose: The Operational Readiness Manager is responsible for ensuring that all facility systems, processes, and personnel are fully prepared to support the start-up and ongoing operations of a medical device manufacturing facility.
This role coordinates cross-functional efforts to ensure compliance with regulatory requirements, efficient operational workflows, and readiness of all vital infrastructure.
Working closely with engineering, quality, safety, and operations teams, this role ensures that the facility meets operational, quality, and safety standards to support production in a highly regulated environment.
This role is responsible for leading and ensuring the project progress throughout the project leading the expedition of key activities across function, find solutions to key problems, and communicate ops readiness elements to the project leader.
A suitable candidate for this role will have excellent leadership experience on all aspects of operational readiness and startup as it specifically relates to FM, EHS, maintenance and C&Q.
They will also have sound experience and knowledge of process engineering and product in medical devices.
Key relationships include collaboration of with E&PS functions (Real Estate, FM and Service Partners) CCFS, EHS, ITS and affiliate Engineering Groups across other functional areas, establishing highly collaborative working culture, key partners and Business leaders.
You will be responsible for : * Lead the development and implementation of operational readiness plans for new and existing facilities.
* Collaborate with project managers, engineering, and quality teams to develop schedules, timelines, and achievements for facility readiness.
* Ensure that all facility operations align with applicable regulations and standards, including FDA, ISO 13485, and GMP guidelines.
* Site , facilities, maintenance, safety and utilities operational readiness * Ensure accurate staff for GT/BT systems walkdown * Own and establish calibrations program for all utilities and facilities equipment * Own deployment of the MAXIMO system * Ensure creation of backup plan for preventing maintenance and Calibrarion Maintenance Management System to support all startup activities * Create and own all maintenance procedures for site operations * Own relationship of " handoff " between FM and the business units Requirements: * B.S.
in Business, Engineering, Architecture or Construction Management from an accredited institution or equivalent required * Project Management Professional (PMP) or equivalent preferred.
* Minimum 8 years of project management experience supporting major capital projects / relative business experience and project or operations management * Extensive knowledge of engineering / construction / projects controls execution.
* Knowledge and experience of translating complex business needs into clear Final Project Objectives.
* Track record of developing and maintaining highly collaborative partnerships at all levels within the organization * Familiarity with J&J Project Management approaches (FPX & IDEA Project Delivery Process) * Experience in an FDA regulated industry * Prior experience managing complex capital projects > $100MM in Supply Chain, R&D, Pharma and Med Device.
* Highly skilled listening and problem-solving skills when managing potential project conflicts.