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SENIOR MICROBIOLOGY & STERILISATION ENGINEER

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 

Job Overview

 

Job Title: Senior Microbiology & Sterilisation Engineer

 

Works with Operations, Product Development Teams and / or external customers to plan and execute Sterilization Validation Activities. Supports key sterilization programs such as sterile load process review and revalidation activities and other related activities such as product bioburden monitoring. Ownership of site product bioburden program. Responsible for the management of the site environmental monitoring program. Responsible to monitor and implement changes to respective programs as improvements or updates are identified. 

 

TE Connectivity’s Quality and Reliability Engineering Teams analyze the ability of product and production systems to comply with customer and contractual requirements through established reliability factors. They design, recommend revisions and install quality control systems, develop and document analytical methods for establishing reliability of products and their components and conduct analysis on relative reliability with regards to cost, structure, weight, maintainability, facility of production, and availability of materials and equipment. Out teams develop, implement and monitor company environmental safety programs and policies to ensure compliance with federal, state, and local environmental, health and safety regulations and recommend corrective actions if necessary. They are responsible for policies and practices to comply with applicable government regulations and industry requirements related to product environmental compliance, the implementation and management of technical and testing standards and specifications, quality control and reliability programs governing materials, product and processes, resulting in the optimization of material and labor, as well as failure analysis, root cause, corrective action and customer communication.

 

Job Responsibilities

 

  • Creation and approval of Sterilization Validation Protocols and Report.
  • Review and Approval of test results and associated test method validations.
  • Collaboratively works with external contract sterilization test facility.
  • Assess/Coordinate cycle consolidation opportunities.
  • Support Operations and Design Service Project Teams with respect to validation of product in approved cycles.
  • Management of process deviations, NCRs and CAPAs related to Sterilization Processes.
  • Support of Operations and Design Service Project Teams with ancillary Sterilization activities such as test unit preparation and dunnage management.
  • Knowledgeable of the associated Quality System requirements and interpretation of same ISO/FDA/AAMI related to sterilization.
  • Responsible for maintenance of site Sterilization and Controlled Environment procedures.
  • Conduct supplier auditing as required.
  • Ownership of site product bioburden program.
  • Management of the site environmental monitoring program.
  • Gives guidance on cleanroom control with respect to monitoring, routine operations, impact of non-conformances and assessment of change.
  • Assess changes to products and processes for impact on sterilization and the controlled environments. 
  • May perform other duties as assigned.
     
Qualifications

 

  • Level 8 Degree in Science/Engineering.
  • 5 years of demonstrated experience in the medical device or pharmaceutical industry with experience specific to ethylene oxide sterilization cycle development and maintenance.
  • Knowledge of medical device products and regulations.
  • Experience in industrial ethylene oxide sterilization; including microbial inactivation kinetics.
  • Microbiological experience in environmental monitoring, and laboratory procedures preferred.
  • Auditing experience.

 


Key Requirements

 

  • Familiarity with regulations and standards published by FDA, USP, AAMI, ANSI, ASTM, and ISO.
  • Demonstrated decision making skills and effective problem-solving abilities.
  • Familiarity with the operation and maintenance of environmentally controlled manufacturing and testing facilities.
  • Knowledge and experience of Ethylene Oxide Sterilisation validation and routine control required. 
  • Knowledge of Microbiological and Environmental monitoring programs preferred.
  • Proficient in the following computer software applications: Microsoft Office.
  • Exceptional interpersonal skills.
  • Strong organizational skills.
  • Strong communication skills (written and verbal).
  • Ability to effectively communicate both internally and externally.
  • Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals.
  • Technical Writing skills.
     
Competencies
Values: Integrity, Accountability,Teamwork, Innovation

About TE Connectivity
TE Connectivity Ltd., is a $14 billion global technology and manufacturing leader creating a safer, sustainable, productive, and connected future. For more than 75 years, our connectivity and sensor solutions, proven in the harshest environments, have enabled advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With 80,000 employees, including more than 8,000 engineers, working alongside customers in approximately 140 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.com and on LinkedIn, Facebook, WeChat and Twitter.

What TE Connectivity offers:

We offer competitive rewards & compensation. Our commitment to our employees includes offering benefit programs that are comprehensive, competitive and will meet the needs of our employees.

  • Competitive Salary Package
  • Performance-Based Bonus Plans
  • Health and Wellness Incentives
  • Employee Stock Purchase Program
  • Community Outreach Programs / Charity Events
  • Employee Resource Groups
Location: 

Galway, G, IE, H91

Travel:  None
Requisition ID:  51050
Alternative Locations: 
Function:  Quality

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. 


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