Global Sterilization Project ManagerPurpose/Role StatementThe Global Sterilization Project Manager is responsible for providing project management leadership of critical EO projects/activities and global EO initiatives for the Coventry EO site and other BSC and contract EO sites. This role will provide technical expertise in the areas of EO processes, equipment and advanced EO technology systems and will involve managing EO facility equipment modifications/upgrades, adding new equipment, EO sterilization IQ, OQ, PQ studies/requirements and various EO safety initiatives.

Key ResponsibilitiesProject management leadership will involve management of multiple projects for multiple EO sites (BSC and Contract), from minor to major facility modifications/upgrades, IQ, OQ and PQ responsibilities for new and existing sterilization equipment, process/safety improvements and work closely with Engineering, OPS and QA for trouble shooting/problem solving of EO related issues. This role will also work with Corporate Sterilization Services (CSS) on various sterilization process validation initiatives.

Experience in EO Sterilization Project Management and Engineering is required.

·Develop and manage project plans: schedule, costs, resources, write/execute test protocols and develop technical reports for EO sterilization processes

·Managing and coordination of resources for day-to-day operations for projects until completion

·Developing and applying sterilization process technology(s) and science to optimize and expand/improve plant capabilities, plant upgrades and modifications.

·Project engineering; new chamber/equipment installations, validations (installation, operational, and production), cost-benefit analysis, training, facilities planning, manufacturing and industrial engineering.

·Responsible for management and oversight/execution of IQ, OQ and PQ for new and existing sterilization equipment and processes

·Monitor and report on project results/status (regarding all quality, lead-time, financial and other applicable goals)

· Manage and control capital project spending within approved budget constraints- Capital Project Management budgets in excess of 10M is expected

·Prioritizing project tasks, develop timelines and report-out milestone

·Apply state-of-the-art process technology and science to support Sterilization Operational and Quality goals and work to reduce COGS related to sterilization operations.

·Will serve as one of the technical resource experts in BSC in supporting sterilization initiatives and will interact with Engineering, Operations and Capacity/Supply Chain Planning.

·Maintain technical proficiency within the EO industry (AAMI, NFPA, EOSA)

·Benchmark best EO practices using world-class companies.

·Conduct departmental meetings (if applicable)

·Cross-functional teams along with communication of project status to company management.

·Analytical and statistical measurement systems required

·Problem solving/trouble-shooting techniques are required. Specifically related to EO processes ad equipment.

·Experience in the medical device industry is required.

·Support sterilization Supply Chain across business units and all BSC sitesExperience in EO Sterilization Project Management and Engineering is required.

Qualifications

·BS Degree (Engineering/Scientific field) is required. Advance degree preferred

·10 years of relevant industry experience preferably within the medical device or a similarly regulated industry w/ 5 years in a sterilization discipline.

·Project Management Professional Certification Preferred

·Advanced technical training in area(s) of EO sterilization is preferred

·Strong written and oral communication skills.

·Supervisory experience is required.

·Complete knowledge and understanding of medical device manufacturing and processing

·Expertise in all areas in the medical products industry with compliance to GMPs, FDA, SOPs, ISO, EPA, OSHA and internal quality systems.

· Six Sigma knowledge and experience are a big plus.

· Demonstrates leadership ability and ability to communicate with all levels of management and employees.

Willingness to travel - 25%



Demonstrated leadership capabilities (Communication skills, initiative, Teamwork, Developing self and others, Stimulate innovation) and the ability to integrate cross-functional activities & apply broad business knowledge to assist in setting strategic directionJob type: Full TimeEducation: BachelorExperience: More than 5 years


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