Role Summary:

  • A new opportunity has arisen for a Lab Validation Engineer based on our client’s busy pharmaceutical site in Co. Waterford.
  • The Validation Engineer has a key role in ensuring the on-going validation compliance of equipment, systems and processes on site in both solid dosage forms and sterile products manufacturing.

Core Duties and Responsibilities:

  • Integrally involved in the validation of all new equipment, processes and control systems on site.
  • Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for equipment, process, cleaning, utility, methods, and computerised systems.
  • Participates in the change control process advising on validation issues, as appropriate
  • Hands on role in the development and execution of DQ, IQ, OQ and PQ activities.
  • Ensures projects are managed in compliance with all required site and legal requirements (Health & Safety, cGMP, construction, environmental etc).
  • Designs, implements and executes validation studies for manufacturing and control equipment. Additional responsibilities for critical systems and facilities as well as validation studies to satisfy regulatory compliance.
  • Provide technical assistance on current US FDA and EU validation requirements for solid dose manufacture and lyophilization, aseptic processing and sterilisation.
  • Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
  • Maintain validation documentation through the
    • Approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans.
    • Generate/review/approve execution of the validation/revalidation plans.
  • Review and approval of site change controls
  • Ensure compliance to cGMP at all times.

Minimum Qualifications and Experience:

  • Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)
  • Post-graduate studies as appropriate to augment primary degree
  • 3-5 years experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
  • 2-3 years experience in validation environment
  • Project Management Experience
  • Capable of troubleshooting validation issues associated with projects, process development etc.
  • Competent technical knowledge of pharmaceutical plants.
  • Knowledge of requirements for of GAMP, ISPE Baseline guides.
  • Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.
  • Full understanding of relevant quality and compliance regulations
  • Able to execute projects to plan.

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


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Role Details:

Job Title: Lab Validation Engineer
Location: Waterford
Type: Contract
Date: February, 2024
Image of recruitment specialist

Discuss with:

Ruth Holland
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
Share:

Role Details:

Job Title: Lab Validation Engineer
Location: Waterford
Type: Contract
Date: February, 2024
Image of recruitment specialist

Discuss with:

Ruth Holland

recruitment@prochem.ie

Recruitment Specialist

on +353 56 779 0100

Share:

Role Summary:

  • A new opportunity has arisen for a Lab Validation Engineer based on our client’s busy pharmaceutical site in Co. Waterford.
  • The Validation Engineer has a key role in ensuring the on-going validation compliance of equipment, systems and processes on site in both solid dosage forms and sterile products manufacturing.

Core Duties and Responsibilities:

  • Integrally involved in the validation of all new equipment, processes and control systems on site.
  • Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for equipment, process, cleaning, utility, methods, and computerised systems.
  • Participates in the change control process advising on validation issues, as appropriate
  • Hands on role in the development and execution of DQ, IQ, OQ and PQ activities.
  • Ensures projects are managed in compliance with all required site and legal requirements (Health & Safety, cGMP, construction, environmental etc).
  • Designs, implements and executes validation studies for manufacturing and control equipment. Additional responsibilities for critical systems and facilities as well as validation studies to satisfy regulatory compliance.
  • Provide technical assistance on current US FDA and EU validation requirements for solid dose manufacture and lyophilization, aseptic processing and sterilisation.
  • Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
  • Maintain validation documentation through the
    • Approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans.
    • Generate/review/approve execution of the validation/revalidation plans.
  • Review and approval of site change controls
  • Ensure compliance to cGMP at all times.

Minimum Qualifications and Experience:

  • Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)
  • Post-graduate studies as appropriate to augment primary degree
  • 3-5 years experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
  • 2-3 years experience in validation environment
  • Project Management Experience
  • Capable of troubleshooting validation issues associated with projects, process development etc.
  • Competent technical knowledge of pharmaceutical plants.
  • Knowledge of requirements for of GAMP, ISPE Baseline guides.
  • Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.
  • Full understanding of relevant quality and compliance regulations
  • Able to execute projects to plan.

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

Image of recruitment specialist

Discuss with:

Ruth Holland
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
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.
Hidden
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