I'm looking for...

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

Google Chrome
Internet Explorer
Mozilla Firefox

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
Paula O'Reilly
Life Science

+353 1 507 9265
[email protected]
Connect with me on
Managing Consultant-Engineering
Republic of Ireland
VP of R&D
Process Engineer
Dublin North
Process Engineer
Data Scientist
Senior GMP Auditor
Republic of Ireland
Principal R&D Engineer
Dublin Greater
Quality Engineer
GMP Inspector
R&D Manager
Process Engineer
Clinical Project Manager
Republic of Ireland
Apply for this job






Salary Expectations:



Current Location:

Notice Period:

Write here your cover note:

If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]

Manufacturing Support Specialist (Clean Room Controls)

Reference:POR875810 Location: Limerick
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Microbiologist

A Manufacturing Support Specialist (Clean Room Controls) is required to join a rapidly expanding Global Biopharmaceutical business in Limerick. This is an opportunity to develop your career with an award-winning business that develop life-changing medicines for serious diseases. This position will report into Manufacturing to provide leadership and direction for clean room contamination control in support of all manufacturing programs; including, but not limited to the manufacturing process and associated clean utilities, qualification and validation activity, microbial sampling/testing practices, data trending, and investigations. Oversees the Manufacturing microbial control for commercial manufacturing production in addition to implementation of improvements.

The Role

  • Ensures that all manufacturing clean room controls are in compliance with cGMP guidelines and applicable regulations.
  • Reviews and provides feedback on area procedures, including SOP’s, master batch documentation, change controls, and validation protocols/reports in accordance with cGMP standards.
  • Chairs reoccurring and ad-hoc cross functional teams in support of manufacturing microbial control initiatives
  • Documents and investigates quality events associated with contamination control of commercial manufacturing to ensure effective root-cause analysis, corrective action plans determination, product impact, and remediation.
  • May develop and deliver microbial control training.
  • Prepares reports and metrics by collecting, analyzing, and summarizing information and trends.
  • Makes decisions; develops and implements policies.
  • Implements preventive and corrective actions to enhance clean room controls.
  • Participates in regulatory inspections and any required follow up actions.

The Person
  • Bachelors degree in Microbiology, Biology or related field
  • 3+ years of relevant cGMP manufacturing experience.
  • Knowledge and experience in pharmaceutical microbiology, cell culture manufacturing, clean utilities, clean room design and operations, and microbial sampling and testing techniques.

For further details please contact; Paula O’Reilly on 087 7094141 or send CV in confidence to [email protected]