Job Description
Our Client:
Our client is a leading Medical Device Global MNC with strong presence in more than 60 countries worldwide. They are global leaders in their respective field.
The Responsibilities:
Responsible for providing subject matter expertise, leading continuous improvement efforts for quality, efficiency, and compliance, in support of the 100% EO terminal sterilization processes at the Huntington facility. Partner with subject matter experts within R&D, and at other contract sterilization facilities in order to meet process improvement, business continuity, and compliance goals.
Major Accountabilities:
Production Support
* Provide subject matter expertise in order to resolve production equipment issues and to provide critical utilities necessary for production sterilization (steam, air, water, etc.)
* Facilitate the collection and dissemination of critical process and equipment information to reduce the reliance on 'tribal' knowledge
Continuous Improvement
* Provide leadership and support for the introduction of new products, equipment and processes within manufacturing
* Continuously develop process expertise within the organization
* Lead the requirements and design development for new equipment/processes
* Lead and/or monitor projects that impact the critical quality attributes of sterilization systems
* Develop and implement sterilization process enhancements and continuous improvements (example: sterilization parametric release)
* Support business continuity plans (example: Design, functional requirements, procurement, installation and validation of new sterilization equipment, back-up sterilization facilities, primary or secondary sterilization to other facilities, sterilization of new product lines, etc.)
Development, Validation & Compliance
* * Ensure that change control procedures are followed
* * Ensure that process and equipment validations focus on critical quality parameters and risk mitigation
* * Ensure that all activities are performed to current standards (current Good Manufacturing Practices cGMP, Health Safety Environment HSE, Regulatory, and compliance with ISO sterilization stds 11135 - etc.)
* * Ensure inspection / audit readiness and provide subject matter expertise for inspections / audits
* * Resolve audit observations relating to sterilization systems
* * Support annual revalidation / periodic review efforts for critical sterilization systems
* * Monitor critical quality data, and proactively resolve potential excursions
* * Maintain / improve sterilization facility local, state, national and international compliance position, perform sterilization (EO, steam, clean steam systems and contract sterilization) related validations and requalifications, maintain compliance to internal and external audits results, maintain compliance WV Dept of Environmental Protection Air Quality Permits and WV Dept. of Labor steam boiler inspection and operational requirements
* * New Provide sterilization support for all new IOL products and delivery systems, provide sterilization adoptions and validations, and provide support for developing cycle parameters, design and development of new products for selection and sterilization compatibility of materials and packaging
Key Performance Indicators
* Robust manufacturing process, delivering critical quality attributes
* No critical observations during internal and external GMP inspections and Pre-Approval Inspections (PAI)
* Change procedures are followed
* Projects achieve schedule and performance goals and are tracked and communicated to plant leadership
* Performance management procedures followed
* Meets individual performance goals and indicators as defined in annual objectives
The Requirements:
* Bachelor degree in Engineering / Chemistry or related discipline
* Masters degree in Engineering / Chemistry or related discipline
* 7-10 years experience in 100% EO terminal sterilization of medical devices
* Project management and team leadership experience
* Regulated industry experience
Disclaimer: The Company complies with the Tripartite Guidelines on Fair Employment Practices (TGFEP), including the prevailing guidelines on recruitment. All qualified applicants will be considered for the position regardless of their age, race, religion, nationality, marital status, or family responsibilities. A more detailed discussion of the TGFEP is available on the Tripartite Alliance for Fair and Progressive Employment Practices (TAFEP) website at https://www.tal.sg/tafep.