Role Purpose:

  • A fantastic opportunity has arisen for a Validation Engineer to join our client’s biopharmaceutical facility in Co. Waterford.
  • In the Validation Engineer role, you will be required to support new product introductions, equipment qualification and the site requalification program.
  • The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes on site.
  • This role is a hybrid position with flexibility to come to site when required.

 

Core Duties and Responsibilities:

The following activities will be included as part of your role:

  • Designing, executing and reporting on PQ Performance Qualifications.
  • Designing, executing and reporting on validation studies for equipment, systems and processes.
  • Ensuring validation studies are managed in conjunction with all required company standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.)
  • Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation.
  • Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times
  • Maintaining validation documentation through the validation lifecycle
  • Participation in external regulatory inspections
  • Support Site Change Control process

 


 

Education & Qualifications Required:

  • Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec)
  • 3-5 years’ experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
  • Capable of troubleshooting validation issues associated with projects, process development etc.
  • Competent technical knowledge of pharmaceutical plants.
  • Previous validation/product development experience would be highly advantageous for the role.
  • 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.
  • Good knowledge of quality management systems.
  • Good communication skills at organisation, team and individual levels.
  • Ability to use MS Project and SPC packages an advantage
  • Understands KPI’s for the site
  • Natural influencer and works well as part of a multifunctional team.
  • Highly motivated and self-resilient.
  • Adaptable and flexible as well as a pragmatically minded problem solver.
  • Sees projects/tasks through to completion.

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


Apply Now

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Role Details:

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

Discuss with:

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

Role Details:

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

Discuss with:

Ruth Holland

recruitment@prochem.ie

Recruitment Specialist

on +353 56 779 0100

Share:

Role Purpose:

  • A fantastic opportunity has arisen for a Validation Engineer to join our client’s biopharmaceutical facility in Co. Waterford.
  • In the Validation Engineer role, you will be required to support new product introductions, equipment qualification and the site requalification program.
  • The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes on site.
  • This role is a hybrid position with flexibility to come to site when required.

 

Core Duties and Responsibilities:

The following activities will be included as part of your role:

  • Designing, executing and reporting on PQ Performance Qualifications.
  • Designing, executing and reporting on validation studies for equipment, systems and processes.
  • Ensuring validation studies are managed in conjunction with all required company standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.)
  • Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation.
  • Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times
  • Maintaining validation documentation through the validation lifecycle
  • Participation in external regulatory inspections
  • Support Site Change Control process

 


 

Education & Qualifications Required:

  • Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering Chemical/Mech/Elec)
  • 3-5 years’ experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
  • Capable of troubleshooting validation issues associated with projects, process development etc.
  • Competent technical knowledge of pharmaceutical plants.
  • Previous validation/product development experience would be highly advantageous for the role.
  • 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.
  • Good knowledge of quality management systems.
  • Good communication skills at organisation, team and individual levels.
  • Ability to use MS Project and SPC packages an advantage
  • Understands KPI’s for the site
  • Natural influencer and works well as part of a multifunctional team.
  • Highly motivated and self-resilient.
  • Adaptable and flexible as well as a pragmatically minded problem solver.
  • Sees projects/tasks through to completion.

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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