I'm looking for...
close

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.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Job Tools
Contact Info
Angela McCauley
Life Science

+353 87 696 0951
[email protected]
Connect with me on
Hot Science Jobs
Engineering Shift Technician
Dublin
Microbiology Manager
Dublin
Product Development Engineer
Dublin
Biostatistician
Dublin City Centre
Project Engineer
Limerick
Electronic Engineer
Dublin
Product Application Specialist (IVD) - I
Dublin
R&D Engineer
Galway
Advanced Technologies R&D Manager
Clare
Senior Regulatory Affairs Specialist
Dublin
Staff R&D Engineer- Customer Focus
Dublin
R&D Engineer
Galway
Mechanical Technician - 2 Cycle
Carlow
Senior R&D Engineer
Galway
Senior Equipment Design Engineer
Dublin
Quality Engineer
Galway
Quality Engineer
Wexford
Senior QC Microbiology (Shift)
Dublin
Senior Regulatory Affairs Specialist
Athlone
R&D Manager
Galway
Product Development Engineer II
Athlone
Principal Engineer
Dublin
Electronic Design Engineer
Galway
Electronic Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Product Development Engineer II
Athlone
R&D Engineer
Galway
Senior R&D Engineer
Galway
Quality Specialist
Tipperary
QA Manager
Canada
R&D Senior Program Manager
Galway
Senior Equipment Design Engineer
Dublin
Senior R&D Engineer-New Product Deve
Westmeath
Senior Technical Transfer Specialist
Cork
MS&T Associate Director
Dublin
R&D Manager
Dublin
Value Stream Team Leader / Production Su
Wexford
Production Operator
Carlow
Clinical Project Manager
Cork
Senior R&D Manager - Lifecycle Manag
Galway
R&D Engineer
Galway
Operations Engineer
Galway
Senior Process Development Scientist
Dublin
Principal Process Development Engineer
Dublin
Senior QC Microbiology (24/7 Shift)
Dublin
Quality Assurance Engineer
Longford
Reliability Engineering Consultant - Rem
Republic of Ireland
Project Manager - R&D
Galway
Electronic Engineering
Dublin
QA Engineer
Leitrim
Product Development Engineer
Dublin
Senior Electronics Engineer
Limerick
Senior Regulatory Affairs Specialist
Westmeath
Maintenance Technician
Carlow
Technical Administrator
Tipperary
R&D Manager
Galway
Quality Engineer
Galway
Regulatory Affairs Associate
Cork
Principal R&D Engineer
Dublin
R&D Manager
Galway
QC Instrumentation Engineer
Limerick
Quality Systems Manager
Dublin
Principal Equipment Engineer
Dublin
Biomedical Engineer
Dublin
Senior Design Assurance Engineer
Athlone
Senior R&D Engineer
Dublin
Senior Regulatroy Affairs Specialsit
Galway
Process Engineer
Galway
Senior Polymer Development Engineer
Galway
Compliance Specialist
Carlow
Quality Technician
Dublin
Senior R&D Engineer
Galway
Senior Recruitment Consultant
Republic of Ireland
Process Engineer (NPI)
Carlow
Senior Equipment Design Engineer
Dublin
Production Operator
Dublin
Quality Engineer
Athlone
Senior R&D Engineer
Galway
Senior Associate Quality Control
Dublin
Senior R&D Engineer
Dublin
R&D Manager
Connaught
Operations Engineer
Galway
R&D Engineer
Clare
Quality Engineer
Galway
Lead Maintenance Reliability Engineer
Westmeath
R&D Engineer
Galway
Principal Software Engineer
Athlone
Senior Reg Affairs Specialist - Post Mar
Galway
Quality Technician
Dublin
Quality Engineer
Galway
CTO
Dublin
Manufacturing Technician
Clare
Senior Recruitment Consultant
Republic of Ireland
Quality Control Technician
Carlow
R&D Manager
Galway
Sales/Customer Service Administrator
Clonmel
Quality Specialist
Tipperary
Senior Quality Engineer
Galway
Quality Specialist & Deputy RP
Limerick
Bioanalytical Senior Principal Scientist
Limerick
R&D Engineer
Galway
Maintenance Reliability Engineer
Tipperary
Senior Quality Engineer
Leitrim
Senior Quality Engineer
Dublin
QA Manager
Canada
Principal Engineer
Dublin
Project Manager - R&D
Galway
Senior Quality Engineer
Dublin
R&D Director
Galway
Product Development Engineer II
Athlone
Senior Process Engineer
Cork
Applications Scientist
Dublin
Senior Recruitment Consultant
Dublin
Director of Regulatory Affairs
Galway
Process Engineer
Cork
Senior Electronic Engineer
Dublin
Senior Design Assurance Engineer
Clare
Senior Operations Engineer
Galway
Head of R&D
Galway
Senior Clinical Project Manager
Dublin
Senior Associate Quality Control
Dublin
Quality Technician
Dublin
Maintenance Reliability Engineer
Cork
R&D Technician II
Galway
Clean Utilities Engineer
Carlow
Senior Manufacting Engineer
Republic of Ireland
Senior R&D Manager - Lifecycle Manag
Galway
R&D Engineer
Galway
VP of Operations
Dublin
Lead Project Engineer
Carlow
Cleaning Validation Specialist
Cork
R&D Project Manager
Galway
Program Manager
Dublin
Clinical Trial Quality Representative
Cork
Notified Body Product Assessor -Active D
Canada
Associate R&D Engineer
Galway
Senior Electronic Engineer
Dublin
R&D Engineer
Galway
R&D Manager
Connaught
SAP Analyst - Logistics & Supply Cha
Limerick
Principal Equipment Engineer
Dublin
R&D Director
Galway
Senior QA Associate (Shift)
Dublin
Account Manager UK and Ireland
Republic of Ireland
Embedded Software Engineer
Dublin
R&D Engineer
Galway
QC Laboratory Technician
Carlow
Senior Quality Engineer-Remote
Republic of Ireland
Senior Validation Engineer
Carlow
Clinical Research Associate
Cork
Process Engineer (NPI)
Carlow
Electronic Engineer
Dublin
Senior Mechanical Engineer
Dublin
Project Manager Design Assurance
Galway
R&D Director
Galway
Quality Manager - NPI
Dublin
R&D Lifecycle Manager
Connaught
MS&T Associate Director
Dublin
Senior Electronics Engineer
Dublin
Chief Medical Officer
Dublin
Maintenance Technician
Kilkenny
Electronic Engineer
Dublin
Engineering Business Manager
Dublin
R&D Technician II
Galway
QC Bioanalytical Analyst
Dublin North
Product Development Manager
Galway
R&D Engineer
Galway
Production Operator
Meath
Cleaning Validation Specialist
Cork
Quality Engineer
Galway
Sr. Associate - Quality for Computer Sys
Cork
Senior R&D Engineer
Galway
R&D Manager
Athlone
R&D Program Manager
Dublin
Senior R&D Manager/Director
Dublin
Product Development Engineer
Dublin
Senior Process Engineer
Cork
R&D Engineer
Dublin
Senior R&D Project Manager
Galway
R&D Engineer
Galway
Senior Cleaning Validation Engineer
Carlow
Senior Process Development Engineer
Galway
Quality Engineer
Galway
Process Chemist
Limerick
Senior R&D Manager
Athlone
Validation Specialist - 50/50 remote
Carlow
Project Engineer - Senior
Cavan
Principal Quality Engineer
Galway
Quality Control Technician
Carlow
Senior Operations Engineer
Galway
Production Operator
Meath
R&D Manager
Connaught
R&D Engineer
Dublin
Senior Electronic Design Engineer
Dublin
Manufacturing Technician
Clare
Manufacturing Technician
Clare
R&D Manager
Athlone
Utilities Engineer - Black Utilities
Roscommon
Responsible Person (RP)
Republic of Ireland
Manufacturing Engineer
Galway
Senior Project Manager - Process Develop
Dublin
Medical Writer
Cork
Senior Tech Transfer Specialist
Meath
Operations Manager
Wexford
Senior Equipment Engineer
Dublin
Manufacturing Engineer
Cork
Technical Services Manager
Tipperary
QA Operations Specialist (hybrid)
Meath
Senior R&D Engineer
Galway
Product Development Engineer
Galway
Technical Life Cycle & Engineering M
Galway
Regulatory Affairs Specialist
Cork
Business Systems Director
Louth
Quality Specialist
Clare
Mechanical Design Engineer
Germany
Commisioning and Qualification Engineer
Cork
R&D Engineer
Galway
Associate Director - Global Core Labelin
Cork
Senior R&D Engineer
Galway
Senior Analytical Scientist
Cork
(Senior) Manufacturing Engineers - Globa
Limerick
R&D Manager
Connaught
Project/Process Engineer - Purification
Cork
Senior Quality Engineer
Leitrim
Strategic Automation Lead
Waterford
Quality Engineer
Galway
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

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]
Details

Senior Cleaning Validation Engineer


Reference:AMC22966 Location: Carlow
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Snr Validation Engineer

11 month contract
Senior Validation Engineer - Cleaning
On site Carlow
AMC22966


We are currently hiring for a Senior Validation Engineer role with a rapidly expanding biopharmaceutical manufacturer based in Carlow. In this role you will support Cleaning validation on site.

The ideal candidate will have 5+ years of experience in validation of sterile fill finish processes and equipment including extensive cleaning validation experience


Responsibilities

  • Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
  • Design/Author/Review/Approve/Execute Execution/development of change controls.
  • Resolving technical issues encountered during study execution.
  • Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
  • Technical input into quality notification by authoring/reviewing/approving investigations.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Serve as validation representative for cross functional projects and represent the validation team at global technical forums
  • Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance
  • Supporting regulatory audits and submissions as required.

Requirements
  • Relevant technical degree
  • Experience in cleaning validation including but not limited to CD & PQ of mobile vessels (CIP) and parts washers (COP) including recipe development & optimisation, cleaning verification, cleanability and recovery studies using TOC, ICP & swab methods, acceptable residual limit determination, worst case soil matrices & strategy development
  • Exception / Deviation Management and Change Control.
  • Demonstratable experience of leading technical related projects.
  • Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile Fill-Finish processes and equipment
Desirable
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment
  • Evidence of continuous professional development
  • Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
Knowledge and experience of the below areas will be considered advantageous:
  • Filter Validation
  • CCI qualification
  • Shipping Qualification
  • Equipment Periodic Validation
  • Equipment Validation Lifecycle
  • Project Management Skills/Qualification
  • Autoclave/SIP Sterilisation Validation
  • Dry Heat Sterilisation
  • Isolator VHP/HVAC Qualification
  • Controlled Temperature Units/Equipment Qualification
  • Vial and Syringe Processing Technologies

Get in touch with Angela McCauley or apply today