Sterilization and Microbiology Engineer
We are currently recruiting for a fixed-term 12-month contract Sterilization and Microbiology Engineer as part of a new product introduction in Galway.
Job Description:
A career at Celestica is only for those who want to do something extraordinary with a meaningful purpose: imagine, develop and deliver a better future with our customers.
Celestica is a leader in high reliability design, manufacturing and supply chain solutions that bring global expertise to every stage of product development.
You will have the opportunity to work on delivering a fully automated high volume manufacturing line from development stage to full scale production ramp producing world class medical devices in a dynamic, fast moving environment.
As a Sterilization and Microbiology Engineer, you will be responsible for dealing with the three major phases of Quality Management, Quality Planning/Prevention & Corrective Action.
Key Responsibilities:
* Lead validation activities, process/procedure definition and maintain a continuous flow of high quality products to our customers in a medical device environment.
* Support some of our product family in the Med tech sector, liaising with Production, Engineering, Supply Chain and Customer contracts reporting into our Quality Manager.
* Participate in NPI projects, defining customer requirements for the Microbiology and Sterilization area.
* Elaborate and execute Validation Protocols and Reports applicable for these areas for EO Sterilization Process Validations, Cleanroom Validations, Microbiology Laboratory Validation, Water System Validation.
* Support the Cleanroom Cleaning Validation.
* Update the Quality System Documentation and New Document Creation to be aligned to Customer and Regulation requirements for Sustaining.
* Develop and Execute Microbiology Test methods, Method Validation and Method Qualification.
* Lead and follow up on Special Projects with Sterilization and Lab Services Suppliers.
* Leading and participating in new projects preparation and presentation to the Management for Improvements and cost reduction.
* Participate and support during third parties audits such as corporate ISO & FDA Audits to ensure GMP, ISO, QSR Regulations and Standards are followed.
Requirements:
To be successful in this role, you should have:
* A thorough working knowledge of Sterilization Processes, Validation techniques and Cleanroom Monitoring/Standards.
* An ability to effectively communicate with a wide variety of internal and external customers.
* Good knowledge of the Medical Device industry or another highly regulated environment.
* Strong Knowledge in Microbiology test methods like Bioburden testing, Endotoxin Testing, Viable air testing, Surface testing and Compressed air testing, Growth Promotion test/Sterility test.
* Experience in EO sterilization and sterilization validation.
* Good understanding of ISO 13485, ISO 11737 and ISO 11135.
What We Offer:
Market-competitive total reward: flexible salary, fix and variable salary based on goals.
The opportunity to become a key member of the new product introduction team in the Health Tech Quality function driven by innovation where creativity matters.
Training and development opportunities, with us the sky is the limit.
The opportunity to innovate, learn, mentor others and work toward your own vision of career success.
A global, collaborative culture with strong leadership imperatives to foster your growth and professional opportunities.
A sustainable culture where we provide opportunities for employees to give back to the community.