Role Purpose:

  • A new opportunity has arisen for a Process Engineer to join our client’s biopharmaceutical facility in Co. Waterford.
  • The Successful candidate will provide Process Engineering support to existing business as usual daily functions and on-going continuous improvement pre-filled syringe processes.
  • Support in the manufacturing of monoclonal antibody (mAb) commercial products, support technology transfer of new products, support introduction of capacity enablers and to work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.

Core Duties and Responsibilities:

  • The main area of work is to own and deliver projects works under the bracket of continuous improvement in the existing thawing, formulation, filling, filter integrity testing and wash/autoclave areas to support NPI and capacity expansion including but not limited to single use technology vendor selection, component introduction and qualification.
  • Execute Process Engineering activities (cycle development protocol/reports, project improvements, deviations, problem solving, change controls, etc) to schedule and to the appropriate compliance and safety standards.
  • Other responsibilities will be to provide support on the existing Aseptic Syringe Filling Lines which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
  • Support commercial manufacturing through delivery of key performance metrics (SQDCI).
  • Support and participation in Regulatory Audit

Education & Qualifications Required:

  • Degree in an Engineering discipline.
  • Strong problem-solving skills.
  • Strong documentation/protocol generation and execution skills.
  • 3 or more years’ relevant experience in a highly regulated GMP environment.
  • Experience in syringe filling would be a distinct advantage.
  • Ability to lead major investigations
  • Fill Weight Cycle Development experience for a filling machine
  • New product introduction experience to a sterile manufacturing area

Beneficial but not Essential:

  • Full automatic filling line technology experience
  • Experience with various forms of filtration and associated filter integrity testing
  • Experience in sterile manufacturing
  • New product introduction experience
  • Experience with tending and data analysis of filling machine/ ancillary equipment using historian software.

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


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Role Details:

Job Title: Process Engineer
Location: Waterford
Type: Contract
Date: July, 2024
Image of recruitment specialist

Discuss with:

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

Role Details:

Job Title: Process Engineer
Location: Waterford
Type: Contract
Date: July, 2024
Image of recruitment specialist

Discuss with:

Ruth Holland

recruitment@prochem.ie

Recruitment Specialist

on +353 56 779 0100

Share:

Role Purpose:

  • A new opportunity has arisen for a Process Engineer to join our client’s biopharmaceutical facility in Co. Waterford.
  • The Successful candidate will provide Process Engineering support to existing business as usual daily functions and on-going continuous improvement pre-filled syringe processes.
  • Support in the manufacturing of monoclonal antibody (mAb) commercial products, support technology transfer of new products, support introduction of capacity enablers and to work as part of a highly focused and integrated Engineering Team in a Sterile Manufacturing environment.

Core Duties and Responsibilities:

  • The main area of work is to own and deliver projects works under the bracket of continuous improvement in the existing thawing, formulation, filling, filter integrity testing and wash/autoclave areas to support NPI and capacity expansion including but not limited to single use technology vendor selection, component introduction and qualification.
  • Execute Process Engineering activities (cycle development protocol/reports, project improvements, deviations, problem solving, change controls, etc) to schedule and to the appropriate compliance and safety standards.
  • Other responsibilities will be to provide support on the existing Aseptic Syringe Filling Lines which includes Debagger / Ebeam / Delid / Deline / Isolator / Syringe filling machine with multi filling technologies.
  • Support commercial manufacturing through delivery of key performance metrics (SQDCI).
  • Support and participation in Regulatory Audit

Education & Qualifications Required:

  • Degree in an Engineering discipline.
  • Strong problem-solving skills.
  • Strong documentation/protocol generation and execution skills.
  • 3 or more years’ relevant experience in a highly regulated GMP environment.
  • Experience in syringe filling would be a distinct advantage.
  • Ability to lead major investigations
  • Fill Weight Cycle Development experience for a filling machine
  • New product introduction experience to a sterile manufacturing area

Beneficial but not Essential:

  • Full automatic filling line technology experience
  • Experience with various forms of filtration and associated filter integrity testing
  • Experience in sterile manufacturing
  • New product introduction experience
  • Experience with tending and data analysis of filling machine/ ancillary equipment using historian software.

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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