Project Lead-Sterility Assurance Group

Kenny-Whelan & Associates

Ringaskiddy

Kenny-Whelan  (A specialist division of the CPL group) are hiring a  Project Lead-Sterilization   for our client, a global Medical Device plant in Ringaskiddy   18 month contract- Ltd contract or salary option    Contact  Jenn Dinan  on 0860466583 and email  jdinan@kenny-whelan.ie. Project Leader, Sterilization Business Continuity  Department: Microbiological Quality and Sterility Assurance. Reports To: Director MQSA Global Orthopedics Make. OVERALL RESPONSIBILITIES: This is a Project leadership role to manage the Sterilization Business Continuity project for the implementation of sterilization continuity for products required to meet customer demand. As Project Leader, interacting with the Regulatory, Engineering, Quality, Operations, HSE and  Design teams in the UK and Ireland to develop sterilization continuity. This role is in the Microbiological Quality and Sterility Assurance group which is part of the Global Microbiological Quality and Sterility Assurance orgainsation. POSITION DUTIES & RESPONSIBILITIES: Develop and execute detailed project plans in a manner that inspires team members. To cultivate external relationships and forge internal collaboration across all levels of the enterprise. Manage timelines and budgets to successfully deliver the project. Manage expectations with equipment and facilities vendors in order to manage their delivery to agreed contracts. Use FPX to co-ordinate the cross-functional project team members to achieve their targets. Collaborate with the Foundry Virtual team and ensure alignment with both Foundry’s on the equipment being purchased and the process development. Interact with Regulatory, Supply Chain, Planners, Quality, contract facilities & EHS as required and ensure alignment to J&J standards. Manage stakeholders on site and globally and communicate project updates as required. Guide team members in regard to commissioning approach for equipment. essential criteria: Bachelor’s degree in Microbiology or a related discipline with 5 years’ experience. Minimum of 3 years of experience in a medical device or equivalent regulated environment. Proven track record of successfully delivering projects. Strong decision making and problem solving skills. Self-motivated, with focus on Quality, Delivery and Cost. Excellent Planning & Organisational Skills. desirable criteria: Project Management Qualification. Knowledge of Lean Manufacturing processes. Certified Six Sigma qualifications. Validation experience. Application of gamma, X-Ray and Ethylene Oxide sterilization methodology.   All applications will be treated with the strictest of confidence. Contact Jenn Dinan on 0860466583 and email  jdinan@kenny-whelan.ie.

1083 days ago