Role Purpose:

  • A new exciting opportunity has arisen for an experienced Senior Validation Engineer to join our client’s site based in Co. Carlow.
  • This role is for candidates interested in a new challenge in a cGMP regulatory environment.
  • The successful candidate will support Cleaning Validation including Recovery/Cleanability studies.

Core Duties and 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.
  • Work collaboratively to drive a safe and compliant culture on site.
  • May be required to perform other duties as assigned.

Education & Qualifications Required:

  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
  • 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.
  • Considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:
  • Exception / Deviation Management and Change Control.
  • Demonstratable experience of leading technical related projects.
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
  • Evidence of continuous professional development is desirable.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
  • Report, standards and policy writing skills required.
  • Equipment and process validation.
  • Sterile Fill-Finish processes and equipment.
  • Proficiency in Microsoft Office and job-related computer applications
  • Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.

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

Please note, we do not require agency assistance with this role.


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Role Details:

Job Title: Senior Validation Engineer
Location: Carlow
Type: Contract
Date: March, 2025
Image of recruitment specialist

Discuss with:

Pádraig O'Connell
recruitment@prochem.ie
Recruitment Specialist
on +353 21 206 6178
Share:

Role Details:

Job Title: Senior Validation Engineer
Location: Carlow
Type: Contract
Date: March, 2025
Image of recruitment specialist

Discuss with:

Pádraig O'Connell

recruitment@prochem.ie

Recruitment Specialist

on +353 21 206 6178

Share:

Role Purpose:

  • A new exciting opportunity has arisen for an experienced Senior Validation Engineer to join our client’s site based in Co. Carlow.
  • This role is for candidates interested in a new challenge in a cGMP regulatory environment.
  • The successful candidate will support Cleaning Validation including Recovery/Cleanability studies.

Core Duties and 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.
  • Work collaboratively to drive a safe and compliant culture on site.
  • May be required to perform other duties as assigned.

Education & Qualifications Required:

  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
  • 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.
  • Considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:
  • Exception / Deviation Management and Change Control.
  • Demonstratable experience of leading technical related projects.
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
  • Evidence of continuous professional development is desirable.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
  • Report, standards and policy writing skills required.
  • Equipment and process validation.
  • Sterile Fill-Finish processes and equipment.
  • Proficiency in Microsoft Office and job-related computer applications
  • Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.

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

Please note, we do not require agency assistance with this role.

Image of recruitment specialist

Discuss with:

Pádraig O'Connell
recruitment@prochem.ie
Recruitment Specialist
on +353 21 206 6178
Share:

Apply Now

"*" indicates required fields

Full Name*
Accepted file types: pdf, docx, odt, doc, txt, Max. file size: 32 MB.
Accepted file types: pdf, docx, odt, doc, txt, Max. file size: 32 MB.
This field is hidden when viewing the form
This field is hidden when viewing the form
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