Sterilization Specialist - Deeside, United Kingdom - ConvaTec

ConvaTec

Verified Company

Deeside, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a FTSE 100 global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence and critical care, and infusion care.

Group revenues in 2021 were over $2 billion.

With around 10,000 colleagues, we provide our products and services in over 100 countries, united by a promise to be forever caring.

Our products provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs.

Our search for better is changing the lives of our customers. It's changing the careers of our people too -creating new challenges and opportunities all the time. We're a business that never stands still. Join us on our journey to #ForeverCaring as a Sterilization Specialist, and you won't either.

Job Summary
Works within prescribed GMP/ISO/GLP Standards and ensures compliance to all applicable national and international regulations. Position supports new and existing products and processes performed in a cleanroom manufacturing environment. Provides sterilization engineering and environmental monitoring support to both existing manufacturing operations and new product development. Works with manufacturing and development teams to evaluate, develop and validate appropriate sterilization processes.

Position will have the opportunity to support the environmental monitoring programs within the cleanrooms and interact with Operations and technical teams on trending, excursions and assessing the impact of environmental changes.

This role has a direct impact on the quality of existing products, as well as products during design and development.

Duties and Responsibilities

Responsible for sterilization duties in the Advance Wound Care business unit and mentoring/assisting the sites in AWC BU specific activities.
Develops, control and implements systems, procedures, and Business Unit strategies relating to sterilization for the Wound Care business.
Train and mentor local Business Unit quality, regulatory, manufacturing, and R&D personnel in sterilization concepts, practices, and approaches.
Works within prescribed GMP/ISO/GLP Standards and assures compliance to all applicable regulations
Provides technical solutions to product development teams and manufacturing using microbiological and sterilization theory and practice
Designs, validates, and implements sterilization processes taking into consideration sterility assurance, modality compatibility, product and packaging functionality and process compatibility
Provides support for manufacturing related sterilization operations, interacting with contract sterilizers and test facilities
Provides technical guidance on sterilization needs to Research and Development on new product development
Review all Change Controls relating to sterilization to determine impact and necessary actions for adoption or verification
Supports manufacturing site environmental control programs by establishing trend reviews, responding to excursions, and assessing impact of changes to products, process and environment
Assists in conducting technical audits of suppliers, contract manufacturers and laboratories.
Delivers results and drives continuous improvement. Sets high performance goals and holds selfaccountable for those results

Principal Contacts
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Internal

AWC SMEs, Manufacturing, Supply Chain, Research and Development, Quality Assurance, SEG and Regulatory Affairs personnel

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External

Suppliers of microbiological equipment, laboratory testing services and contract sterilization and environmental monitoring services

Travel Requirements:

Some local and international travel

Education/Experience/Qualifications

BSc in Microbiology preferred. BA/BSc in appropriate science, mathematics or Engineering accepted, or a strong proven experience and background more experience if no appropriate science degree.
Demonstrates knowledge of ethylene oxide (preferred) and radiation validation principles and industry standards and experience in sterilization process controls is a must.
Demonstrates expert technical knowledge of working within a controlled manufacturing environment and has experience in monitoring and maintenance of systems validation of controlled environments using national and international standards

Experience

Have a working knowledge of GMP/ISO/GLP guidelines as applied to medical device sterilization
Have hands on experience in monitoring and maintenance of validation of controlled environment using current guidelines and regulations
Have provision of scientific data to support manufacturing, resolve nonconforming issues and ensure adequate corrective and preventive actions
Have general leadership skills to organize complex work schedules
Be fully competent in oral and