Role Summary:

  • An exciting new opportunity has arisen for a Utilities CQV Engineer to join our client’s busy biopharmaceutical facility based in Co. Dublin.
  • Your role will be to implement the commissioning and qualification of new/modified clean utilities and non GMP utilities and controlled environmental devices sitewide.
  • The successful candidate will provide technical expertise to ensure that systems and equipment are installed, commissioned and qualified to the company’s and regulatory specifications.

Core Duties and Responsibilities:

  • Generate documentation for cGMP commissioning/qualification of systems and equipment, including CTP/IQ/OQ/PQ protocols and reports.
  • Raise and implement system change controls and ECM’s.
  • Participate in design review for new/ modified utility systems.
  • Participate in construction system mechanical completion walk downs.
  • Perform execution of CTPs, IQ, OQ, PQ Protocols in field.
  • Perform execution of temperature mapping of equipment.
  • Perform pre- and post-study calibration verifications.
  • Operate according to SOPs developed for validation, validated manufacturing operations and cGMP compliance.
  • Develop and implement changes required to resolve deviations/ events effectively.

Minimum Qualifications and Experience:

  • Sc/B.Eng. degree in engineering discipline, with particular emphasis on mechanical or process engineering.
  • Minimum of 3-5 years’ experience from biotechnology or pharmaceutical GMP manufacturing environment.
  • Experience in temperature mapping with lives xpertval system is an advantage.
  • Experience with qualification of clean utilities and HVAC.
  • Demonstrated ability to work on own initiative and proactively respond to business needs.
  • Excellent interpersonal and communication skills.
  • Experience in good documentation practice.
  • Experience in reading/verifying P&IDs.

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


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Role Details:

Job Title: Utilities CQV Engineer
Location: Dublin
Type: Contract
Date: February, 2024
Image of recruitment specialist

Discuss with:

Lewis Murray
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
Share:

Role Details:

Job Title: Utilities CQV Engineer
Location: Dublin
Type: Contract
Date: February, 2024
Image of recruitment specialist

Discuss with:

Lewis Murray

recruitment@prochem.ie

Recruitment Specialist

on +353 56 779 0100

Share:

Role Summary:

  • An exciting new opportunity has arisen for a Utilities CQV Engineer to join our client’s busy biopharmaceutical facility based in Co. Dublin.
  • Your role will be to implement the commissioning and qualification of new/modified clean utilities and non GMP utilities and controlled environmental devices sitewide.
  • The successful candidate will provide technical expertise to ensure that systems and equipment are installed, commissioned and qualified to the company’s and regulatory specifications.

Core Duties and Responsibilities:

  • Generate documentation for cGMP commissioning/qualification of systems and equipment, including CTP/IQ/OQ/PQ protocols and reports.
  • Raise and implement system change controls and ECM’s.
  • Participate in design review for new/ modified utility systems.
  • Participate in construction system mechanical completion walk downs.
  • Perform execution of CTPs, IQ, OQ, PQ Protocols in field.
  • Perform execution of temperature mapping of equipment.
  • Perform pre- and post-study calibration verifications.
  • Operate according to SOPs developed for validation, validated manufacturing operations and cGMP compliance.
  • Develop and implement changes required to resolve deviations/ events effectively.

Minimum Qualifications and Experience:

  • Sc/B.Eng. degree in engineering discipline, with particular emphasis on mechanical or process engineering.
  • Minimum of 3-5 years’ experience from biotechnology or pharmaceutical GMP manufacturing environment.
  • Experience in temperature mapping with lives xpertval system is an advantage.
  • Experience with qualification of clean utilities and HVAC.
  • Demonstrated ability to work on own initiative and proactively respond to business needs.
  • Excellent interpersonal and communication skills.
  • Experience in good documentation practice.
  • Experience in reading/verifying P&IDs.

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

Image of recruitment specialist

Discuss with:

Lewis Murray
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.
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