Connecting to LinkedIn...

Vacancy Details

Science Pharmaceutical and Food

106341 - Senior Microbiology & Sterilisation Engineer - Galway

Contract Type: Permanent
Location: Galway
Date: 16/01/2020
Job Reference: 106341
Contact Name: Clara Burke
Contact Email:

Job Description

Senior Microbiology & Sterilisation Engineer - Galway - 106341
Senior Microbiology & Sterilisation Engineer

Our client, a medical device company in Galway is currently looking to recruit a Senior Microbiology & Sterilisation Engineer for their site.

Working 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.

Quality and Reliability Engineering Teams analyse 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 labour, 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.

  • 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.

For further information on this Senior Microbiology & Sterilisation Engineer role in Galway please contact Clara Burke on 086 8168273 /

Check out all our open jobs on our HERO Recruitment website –
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Share this Job

“I have worked with HERO recruitment (formerly HERO recruitment) for a number of years both within my current and previous position. I have always found HERO recruitment excellent to partner with, the consultants know our industry and cultural fit and can therefore successfully source high calibre candidates to match our open vacancies. I find HERO recruitment very professional to deal with and any candidates I interview who are sourced by HERO always have a positive recruitment experience”.

Moira Faherty,
Human Resources Manager
Chanelle Group

“My very first impression was that I was dealing with a recruitment company who were extremely professional, supportive and knowledgeable of the role for which I was applying. Not only were the responsibilities of the role explained to me in great detail, but they also went to great lengths to really understand the depth of my technical, managerial and leadership experience and capabilities. What impressed me the most was their personal touch in building a strong relationship with me as a candidate and in maintaining regular contact with me on the status of the role throughout the application process”.

Adrian Rice,
Engineering Manager 
Boston Scientific

“HERO have been a key strategic recruiting partner to Hollister ULC over many years. During our continued growth and expansion at our facility in Ballina, Hero have worked closely with us to really understand our recruiting needs, the calibre of talent we are looking for, and the fit for our Hollister culture. HERO have successfully sourced and placed candidates for us into Research and Development, Project / Process Engineering, Supply Chain and key Management roles.  They have a very experienced and professional team, and bring an excellent regional, national and international perspective”. 

Tom Horkan,
Asst. HR Manger
Hollister ULC, Ballina, Co. Mayo

"From the first prompt call-back to the ultimate congratulatory call to inform me of a job offer, Karl was an absolute professional; sound advice, solid research and knowledge of companies, unwavering persistence and friendly encouragement. West is best, so for anyone looking for a technical role, talk to Karl"

Fiachra Collins
Computer Vision Algorithm Team Manager

“HERO Recruitment continues to be a valued partner in supplying high calibre candidates to all three Boston Scientific sites in Ireland. In particular they have been successful in delivering on specific roles for key project scale-ups. HERO has also provided on-site recruitment presence during increased activity when required and consistently operate in a highly professional and competent manner”.   

Lorraine McDonnell,
Senior Talent Acquisition Specialist
Boston Scientific 

“HERO Recruitment were instrumental in sourcing and delivering key talent to the organisation and enabled us to meet our key deliverables within our start-up phase. They thoroughly understood our culture and constantly over delivered on our expectations. Our partnership with HERO Recruitment has without a doubt been  a professional and collaborative one. HERO exceed themselves in all aspects of recruitment and are an absolute pleasure to work with”.

Christine Power,
VP of Human Resources

“HERO recruitment is an extension to our talent acquisition team. From hiring strategy meeting to the induction of the right talent, the HERO recruitment team provide an exemplary service. They are knowledgeable about our business needs, responsive and thorough. A true talent acquisition partner”. 

Orla Keady-Giblin,
Human Resources Manager
Ingersoll Rand – Thermo King

I am extremely grateful to Anne-Marie at HERO Recruitment for helping me land an opportunity in Ireland. She had a great deal of information regarding the job profile, was extremely prompt in arranging an interview and followed it up brilliantly. She was an excellent point of contact between the employer and me during the whole process. She has good knowledge about the process and was well aware of the timelines. I would recommend Anne-Marie, HERO Recruitment to anyone who is looking for opportunities in the country

Nikhil Pradeepkumar
Optical Engineer
Valeo Vision Systems

Clients we are proud to work with