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General Overview
Functional Area: Quality (QUA)
Career Stream: Operations Quality (OPQ)
Role: Specialist (SPE)
Job Title: Specialist, Operations Quality
Job Code: SPE-QUA-OPQ
Job Level: Band08
Direct/Indirect Indicator: Indirect
Summary
At Celestica, we empower the world's best brands, solving complex technology challenges and fostering trusted relationships. Our global expertise spans high-reliability design, manufacturing, and supply chain solutions, bringing innovation to every stage of product development.
We are currently recruiting for a permanent Microbiology Engineer as part of a new product introduction in Galway! By Joining Celestica Galway (Ireland) as Microbiology Engineer 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.
Your next challenge will be...
To lead validation activities, process/procedure definition and maintain a continuous flow of high quality products to our customers in a medical device environment. This position will be responsible for supporting some of our product family in the Med tech sector liaising with Production, Engineering, Supply Chain and Customer contracts reporting into our Quality Manager.
Detailed Description
Your day-to-day activities will include…
* Participating in NPI projects defining the Customer requirements for the Microbiology
* Elaborating and executing Validation Protocols and Reports applicable for these areas for Cleanroom Validation, Microbiology Laboratory Validation
* Supporting the Cleanroom Cleaning Validation
* Updating the Quality System Documentation and New Document Creation to be aligned to Customer and Regulation requirements for Sustaining
* Development and Execution of Microbiology Test methods, Method Validation and Method Qualification
* Leading and following up on Special Projects with Lab Services Suppliers
* Leading and participating in new projects preparation and presentation to the Management for Improvements and cost reduction
* Participating and supporting during third parties audits such as corporate ISO & FDA Audits to ensure GMP, ISO, QSR Regulations and Standards are followed
What do we expect from you?
* A thorough working knowledge of 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
* Good understanding of ISO standards
Typical Experience
What are we looking for?
* A minimum of 3+ years in Microbiology experience
* Someone with a level 8 degree (credits) or equivalent in Science with Biology or Microbiology related discipline. However, postgraduate qualifications etc. will be considered if supported with relevant experience
* Someone with an ability to initiate and lead change, collaborate and create alignment, drive accountability, think critically and make sound decisions
* Experience of 6 Sigma quality methods would be a distinct advantage
* Someone that is open to the opportunity of short term travel assignments particularly at the early stages of the project
* Demonstrated Experience in drafting and executing test methods, validation plans, protocols reports
* Participating and functional leading for regulated bodies auditing
Notes
This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.
Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law). At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.
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