+353 1 662 1000
+353 21 422 1000
Tel +353 1 662 1000
Tel +353 21 422 1000
Submit a CV
Submit Your Job Spec
Register / Sign in
Find a Job
Connacht (ex. Galway)
Leinster (ex. Dublin)
Munster (ex. Cork)
Republic of Ireland
Ulster (ex. NI)
Northern Ireland (*)
FIND YOUR JOB
Browse jobs by specialisms
My Recent Searches
Browse Jobs by Category
Compliance and Risk
Request a Call Back
Discuss this role with a consultant.
Prefered time to call back
Request a Callback
Back to all search results
Sterility Assurance Lead
04 Nov 2022
Sterility Assurance Lead
About the Company
An opportunity to join one of the premium employers in the South East and lead Sterility Assurance activities at this diversified manufacturing site.
About the Position
In this role you will provide essential support to the sterile manufacturing areas, working with new innovative technologies and developing and improving aseptic processes for recently qualified aseptic processing area. The team provides support on contamination control strategy and implementation, media fills, major investigations, and program support.
Ideally you will hold a Degree or Masters in Microbiology and bring at least 5 years of experience in Pharma/Biologics.
Oversee the development and support for strategies regarding to contamination control, media fill, environmental monitoring, PQs, decontamination, sterilisation, dehydrogenation, and management of sterility breaches.
Cleaning validation for microbial properties such as bioburden and endotoxin.
Lead sterility assurance investigations.
Review and approve documentation related to commissioning, PQs, process validation, risk assessments and regulatory related to sterility assurance.
Review specifications for consumables relating to biological indicators and product specifications.
Participate in audits and inspections internally and externally based on sterility assurance aspects.
Involvement in the introduction of modern technologies.
Contribution to programme design, training, and development of new and existing employees.
5+ years’ experience in Pharmaceutical/Biotechnology industry working in aseptic processing.
Degree or higher in Microbiology
Project and/or operational support in Quality/Validation/Microbiology or Manufacturing within an aseptic manufacturing environment
Experience in leadership position is desirable
In depth knowledge of EU & FDA regulatory agencies expectations
A detailed and complete knowledge of international cGMP
Expert knowledge with current international pharmaceutical/biotechnology industry trends
A strong salary range is available along with a great package of benefits.
For more information on the role or any other Engineering or Life Sciences roles call
on 087 3618142 or
or click the apply button below.
To view all live jobs with Brightwater and market insights, please visit our website;