I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Job Tools
Contact Info
Sean McCarthy
Life Science

+3530212339371
[email protected]
Connect with me on
Hot Science Jobs
Quality Assurance Specialist (hybrid)
Dublin
Process Engineer
Leitrim
Senior Project Engineer
Cavan
Senior QC Specialist - Equipment & I
Dublin
Senior Maintenance Technician
Kilkenny
Principal R&D Engineer
Galway
Laboratory Technician
Carlow
Quality Specialist
Dublin
Project Manager (hybrid)
Dublin
Senior Technology Transfer Specialist
Dublin
Senior Quality Systems Engineer
Galway
Senior NPI Engineer - Hybrid
Dublin
Production Manager
Dublin
Senior Quality Assurance Specialist
Cork
Senior QA Associate (Investigation Lead)
Dublin
R&D Engineer
Galway
Quality Engineer
Athlone
Director of R&D
Limerick
Quality Engineer
Galway
R&D Manager
Connaught
Continuous Improvement Coach
Limerick
R&D Engineer
Galway
Production Operator
Meath
Electronic Engineering
Dublin
Quality Engineer
Galway
QA Manager
Canada
Quality Specialist
Clare
Senior Principal R&D Engineer
Galway City
Senior Regulatory Affairs Specialist
Athlone
Director of Regulatory Affairs
Galway
Injection Moulding Engineer
Leitrim
Product Development Manager
Galway
Engineering Business Manager
Dublin
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Dublin
Lead MSAT Validation Consultant
Republic of Ireland
Continuous Improvement Coach
Limerick
R&D Lifecycle Manager
Connaught
Business Development Manager (Hospitals)
Cork
R&D Technician
Galway
Process Chemist
Limerick
R&D Manager
Connaught
Quality Engineer
Galway
Senior R&D Engineer
Galway
Senior R&D Engineer
Clare
Senior Quality Engineer
Dublin
Senior Maintenance Technician
Kilkenny
Senior Electronic Engineer
Dublin
Senior QA Specialist
Dublin
Senior Human Factors Engineer
Galway
Director of Regulatory Affairs
Galway
Validation Engineer
Republic of Ireland
Senior Regulatory Affairs Manager
Galway
Sales/Customer Service Administrator
Clonmel
Dental- Manager/ Senior Manager Business
Republic of Ireland
Laboratory Systems Specialist
Meath
Senior Electronics Engineer
Dublin
Senior Production Supervisor
Galway City
Senior Design Engineer
Dublin
Senior Research & Development Engine
Limerick
Quality Assurance Specialist/Manager
Dublin
Project Manager - New Product Introducti
Dublin
Quality Manager
Galway
Principal R&D Engineer
Galway
R&D Engineer
Galway
Senior Operations Engineer
Galway
R&D Manager
Galway
Senior Electrical Engineer
Galway
Validation & Verification Engineer
Dublin
Quality Manager
Galway
Process Engineer
Galway
R&D Manager
Athlone
Regulatory Affairs Specialist
Cork
Supplier Quality Engineer
Galway
Manufacturing Specialist - Investigation
Dublin
Principal R&D Engineer
Dublin
QC Specialist
Cork
Quality Engineer - Supplier
Galway
Principal R&D Engineer
Galway City
Product Development Technician II
Galway
Quality Technician
Dublin
Senior Design Assurance Engineer
Athlone
Quality Assurance Senior Specialist
Louth
Staff R&D Engineer
Limerick
Quality Assurance Associate
Cork
R&D Engineer
Galway
R&D Technician II
Galway
Product Development Engineer
Galway
Quality Systems Manager
Dublin
Construction Manager - Pharma/Biotech
Dublin
CTO
Dublin
Advanced Technologies Manager
Galway
Project Manager
Kildare
Senior Regulatory Specialist
Cork
Senior Quality Engineer
Dublin
Injection Moulding Engineer
Athlone
QA Operations Specialist
Dublin
Documentation Specialist
Louth
Quality Technician
Dublin
Quality Engineer
Galway
Design Quality Engineer
Galway
Operations Engineer
Galway
Senior Quality Engineer
Dublin
Director of Quality Engineering
Limerick
Principal Engineer
Dublin
Responsible Person (RP)
Republic of Ireland
Quality Engineer
Galway
Commercial Solutions Manager (Medical De
Dublin
Project Manager
Galway
R&D Manager
Galway
Product Specialist (Critical Care &
Dublin
Quality Engineer - Supplier
Galway
R&D Manager
Connaught
Regulatory Affairs Maanger
Galway
R&D Manager
Galway
Advanced Technologies R&D Manager
Clare
Quality Specialist
Tipperary
R&D Engineer
Galway
Product Development Engineer
Dublin
R&D Director
Galway
R&D Engineer
Galway
Senior Equipment Engineer
Dublin
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Principal Process Equipment Engineer
Dublin South
Product Development Engineer II
Athlone
Quality Manager - Medical Devices
Limerick City
Senior Electronics Engineer
Limerick
Biomedical Engineer
Dublin
R&D Manager
Galway
Design Assurance Manager
Galway
Senior QC Associate (Bioassay)
Dublin
Senior R&D Engineer
Galway
Senior Design Engineer
Dublin
Regulatory Affairs Manager- Remote
Republic of Ireland
Senior Manufacting Engineer
Republic of Ireland
Senior Quality Engineer
Leitrim
Business Development Manager
Republic of Ireland
Project Engineer - Senior
Cavan
Associate Quality Assurance Specialist
Tipperary
Supplier Quality Engineer
Galway
Senior Quality Assurance Associate
Dublin
Director Engineering & Supply Chain
Galway
Environmental Health & Safety (EHS)
Longford
Quality Assurance Team Lead
Cork
Quality Assurance Specialist (Hybrid)
Dublin
CTO
Galway
Quality Engineer
Galway
Purchasing & Planning Manager
Wexford
Calibration Technician
Republic of Ireland
Reg Affairs Specialist
Connaught
Principal Engineer
Dublin
Quality Manager
Dublin
Validation Engineer
Athlone
Senior Quality Engineer
Leitrim
Product Specialist (Critical Care &
Dublin
Project Engineer
Roscommon
Principal Design Assurance Engineer
Galway
Senior Quality Engineer
Dublin
R&D Manager
Athlone
Principal R&D Engineer
Galway
Quality Technician
Dublin
Technical Life Cycle & Engineering M
Galway
R&D Senior Program Manager
Galway
R&D Director
Galway
Project Manager
Kildare
QA Specialist (Investigation Lead)
Dublin
Business Resilience Specialist
Dublin
R&D Manager
Galway
Quality Manager
Dublin
Injection Moulding Engineer
Athlone
Quality Assurance Team Lead
Cork
R&D Engineer
Galway
Senior R&D Engineer
Dublin
R&D Engineer
Galway
Senior R&D Engineer II
Galway
Regulatory Affairs Manager - Senior
Galway
Associate Quality Specialist
Tipperary
Senior Quality Engineer
Galway
R&D Manager
Dublin
Senior R&D Engineer
Dublin
Senior QA Specialist
Dublin
Product Development Engineer
Dublin
Senior Design Assurance Engineer
Athlone
Senior Equipment Design Engineer
Dublin
R&D Engineer
Dublin
Manufacturing Engineer
Galway
Application Software Engineer
Galway
Project Engineer
Clare
Technical Life Cycle & Engineering M
Galway
R&D Director
Galway
Senior Process Engineer
Dublin
Senior Regulatory Specialist
Cork
Sr Electrical Engineer
Galway
Supply Chain Project Manager (hybrid)
Dublin
R&D Director
Galway
Project Engineer
Cork
Senior Commissioning & Qualification
Roscommon
QA Engineer
Leitrim
Quality Assurance Specialist (shift)
Carlow
Senior Regulatory Affairs Specialist
Athlone
Senior Quality Control Associate
Dublin South
Documentation Specialist
Louth
Senior Project Engineer
Cavan
Senior Quality Systems Engineer
Galway
Senior R&D Engineer
Galway
Product Specialist - Imaging/ Radiograph
Dublin
Operations Manager
Galway
Senior R&D Engineer
Dublin
Principal Quality Engineer
Galway
Senior Design Assurance Engineer
Galway
Microbiology Manager
Dublin
Principal Engineer
Dublin
Senior R&D Engineer
Galway
Principal Design Assurance Engineer
Galway
Quality Assurance Engineer
Longford
Quality Engineer
Wexford
Senior R&D Engineer
Clare
R&D Manager
Connaught
Principal R&D Engineer
Galway City
Design Assurance Engineer
Galway
Senior Regulatory Affairs Specialist
Clare
Continuous Improvement Coach
Limerick
Learning Systems Lead
Limerick
Senior Process Development Engineer
Dublin
Process Development Engineer
Galway
Quality Engineer
Galway
R&D Engineer
Clare
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Senior Process Development Engineer


Reference:SMC8294 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Process Development Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Biopharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

  • Developing single use systems in collaboration with site teams and network for DP formulation and filling.
  • Authoring / verification of single use qualification packages.
  • Filling characterisation support (Filling recipe development - protocol development / execution and reporting.)
  • Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skills are essential for this role, as well as a demonstrated proficiency with the principles of Technical Writing.
  • Leads and conducts risk assessment for drug product operations and propose / implement appropriate CAPA.
  • Provide process development expertise for drug product processing in specific areas such as sterile processing, process characterization, filling, SUS. Support commercial drug product manufacturing operations with technical evaluation of NC/CAPA and technology transfer. Interfaces with manufacturing as well as all support functions to provide robust and coordinated support to manufacturing.
  • Troubleshoots issues with drug product processing technologies and equipment. Champions use of data-driven analyses and visualizations. Investigates to determine root cause.
  • Responsibilities may include leading cross-site teams to support the above activities, providing recommendations to management.
  • Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards).
  • Review and post-approve process validation protocols and assessments from a quality system documentation perspective.
  • Contribute to product quality assessments and process flow documents.
  • Liaise with Operations, Engineering and external vendors regarding new or amended equipment which would impact the validated process.

Education & Experience
  • A third level Bachelor’s Degree in Science, Engineering or a relevant Quality discipline with 5 years’ experience in a similar role OR Master’s degree & 3 years of directly related experience OR Associate’s degree & 10 years of directly related experience.
  • Thorough knowledge of aseptic manufacturing technologies and cGMP.
  • Strong skills in applying fundamental engineering and scientific principles to the design and implementation of Formulation Single use systems and Filling.
  • Significant experience supporting Commercial Protein Drug Product (DP) processing in specific areas such as Sterile Processing, Process Characterization, Tech Transfer (to commercial DP sites) or Validation.
  • Strong skills in applying fundamental engineering and scientific principles to the design, implementation and process validation of formulation, mixing, filtration and filling. Knowledge of protein biochemistry regarding chemical and physical stability
  • Background in Drug product Filling technologies, Peristaltic pumping / Time pressure filling.

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.