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
Product Development Engineer
Galway
Senior Microbiologist
Dublin
CTO
Galway
Director of R&D
Limerick
R&D Manager
Galway
Senior Mechanical Engineer
Dublin
Quality Assurance Specialist (shift)
Carlow
Product Development Engineer
Dublin
Senior Electrical Engineer
Galway
Quality Technician
Galway
Senior Quality Assurance Specialist
Cork
Process Chemist
Limerick
Process Engineer
Galway
Principal Reliability Engineer
Galway
Quality Technician
Dublin
Quality Manager
Galway
Principal R&D Engineer
Dublin
Engineering Business Manager
Dublin
Documentation Specialist
Louth
R&D Engineer
Clare
Senior Research Scientist
Galway
Business Development Manager
Republic of Ireland
Principal Design Assurance Engineer
Galway
Quality Specialist
Tipperary
Senior QC Microbiology
Dublin
Senior Process Engineer
Longford
Project Manager - R&D
Galway
Senior Equipment Design Engineer
Dublin
R&D Manager
Galway
Product Development Engineer II
Athlone
Accreditation Manager
Republic of Ireland
Responsible Person (RP)
Republic of Ireland
Senior Regulatory Specialist
Cork
Senior Associate QC (QC Sample Managemen
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior Regulatory Affairs Manager
Galway
Senior Design Assurance Engineer
Galway
Senior Regulatory Affairs Specialist
Clare
Documentation Specialist
Louth
Documentation Specialist
Louth
Operations Engineer
Galway
QC Bioanalytical Sciences - Senior Assoc
Dublin
Senior Clean Utilities Engineer
Dublin
Senior QC Associate (Bioassay)
Dublin
Principal Design Assurance Engineer
Galway
Product Development Engineer
Galway
Manufacturing Technician
Clare
Senior Quality Engineer
Leitrim
Health & Safety Specialist
Dublin
Senior Design Assurance Engineer
Athlone
Senior Quality Systems Engineer
Galway
Technical Support Specialist - Drug Subs
Louth
Senior NPI Engineer - Hybrid
Dublin
Purchasing & Planning Manager
Wexford
Principal Design Assurance Engineer
Galway
R&D Engineer
Galway
Senior Electronic Engineer - Regulated M
Galway
Clinical Trial Manager
Republic of Ireland
Senior Electronics Engineer
Limerick
Injection Moulding Engineer
Leitrim
Sterilisation Manager
Tipperary
Senior Manufacturing Engineer
Galway City
Senior Quality Systems Engineer
Galway
R&D Manager
Connaught
R&D Manager
Athlone
Process Development - Senior Project Man
Dublin
Senior R&D Engineer
Galway
Senior Product Development Engineer
Galway
R&D Lifecycle Manager
Connaught
Quality Technician
Dublin
Quality Engineer
Galway
Principal Engineer
Dublin
R&D Manager
Galway
Director Engineering & Supply Chain
Galway
R&D Engineer
Galway
Quality Assurance Specialist (hybrid)
Dublin
Senior Principal Design and Development
Galway
Senior R&D Engineer
Galway
Senior QC Associate
Dublin
Quality Manager
Dublin
R&D Manager
Dublin
Process Development Engineer
Galway
Regulatory Affairs Specialist
Cork
Senior Electronics Engineer
Dublin
Construction Manager - Pharma/Biotech
Dublin
Senior Quality Control Associate
Dublin South
Project Engineer
Clare
Dental- Manager/ Senior Manager Business
Republic of Ireland
Maintenance & Reliability Technician
Limerick
Quality Engineer
Galway
R&D Engineer
Galway
Mechanical Engineer
Dublin
R&D Engineer
Galway
Validation Engineer
Carlow
Senior Process Engineer
Dublin
Design Assurance Manager
Galway
Dental- Manager/ Senior Manager Business
Republic of Ireland
Principal Engineer
Dublin
Senior R&D Engineer
Dublin
Quality Assurance Associate
Cork
R&D Manager
Galway
Commercial Attribute Science Scientist
Dublin
Biomedical Engineer
Dublin
R&D Director
Galway
Senior Maintenance Technician
Kilkenny
Project Manager - New Product Introducti
Dublin
Mechanical Technician
Carlow
Principal R&D Engineer
Galway
QA Engineer
Leitrim
Advanced Technologies R&D Manager
Clare
Laboratory Systems Specialist
Meath
QA Operations Specialist
Dublin
Senior Quality Assurance Specialist (hyb
Dublin
Product Specialist (Critical Care &
Dublin
Senior Operations Engineer
Galway
Senior R&D Engineer
Clare
Electrical Technician
Limerick
Senior R&D Engineer
Galway
Senior Quality Engineer
Dublin
R&D Engineer
Galway
R&D Engineer
Galway
Warehouse Operator
Meath
R&D Engineer
Dublin
Project Manager (hybrid)
Dublin
Program Manager (AVI Lines Operational R
Dublin
Application Software Engineer
Galway
Quality Specialist
Dublin
Senior Quality Assurance Associate
Dublin
R&D Manager
Athlone
Quality Engineer
Galway
R&D Senior Program Manager
Galway
Quality Engineer
Athlone
Senior Design Assurance Engineer
Galway
Director of Quality Engineering
Limerick
Senior R&D Engineer
Galway
Senior R&D Engineer
Galway
Quality Assurance Specialist (Logistics)
Dublin
Product Development Engineer II
Athlone
Validation Engineer
Athlone
Principal R&D Engineer
Dublin
R&D Engineer
Galway
Project Manager
Kildare
R&D Manager
Connaught
Senior R&D Engineer II
Galway
Senior Process Development Engineer
Galway
Senior Regulatroy Affairs Specialsit
Galway
Quality Assurance Senior Specialist
Louth
Inside Sales Representative (IVD Divisio
Kildare
Senior Quality Assurance Specialist
Dublin
Supply Chain Specialist - New Material I
Meath
Senior Process Development Engineer
Dublin
Senior Manufacturing Engineer
Galway
Staff Systems Engineer
Limerick
Design Assurance Engineer
Galway
Manufacturing Technician
Galway
Sr Electrical Engineer
Galway
Senior Quality Engineer
Leitrim
Injection Moulding Engineer
Athlone
Continuous Improvement Coach
Limerick
Senior R&D Manager - Lifecycle Manag
Galway
Senior Equipment Design Engineer
Dublin
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Electronic Engineer
Dublin
Senior Associate Quality Control
Dublin
Facilities Engineer
Wexford
Quality Assurance Team Lead
Cork
Senior Design Engineer
Dublin
Senior Principal R&D Engineer
Galway City
Calibration Technician
Republic of Ireland
Senior Project Engineer
Cavan
Embedded Software Engineer
Dublin
Injection Moulding Engineer
Athlone
Engineering Support Specialist
Louth
Senior R&D Engineer
Dublin
Senior Manufacting Engineer
Republic of Ireland
Senior Associate Quality Control (Shift)
Dublin
Tech Transfer Lead - Sterile Drug Produc
Dublin
Manufacturing Technician
Clare
Senior Product Development Engineer
Galway
Senior Equipment Design Engineer
Dublin
Supply Chain Project Manager (hybrid)
Dublin
Quality Assurance Engineer
Longford
Senior Electronic Engineer
Dublin
R&D Engineer
Dublin
Senior Design Engineer
Dublin
Senior R&D Engineer
Galway
Senior R&D Engineer
Clare
QC Micro Analyst (4 cycle shift)
Cork
Commercial Solutions Manager (Medical De
Dublin
Senior Regulatory Affairs Specialist
Dublin
Principal Process Equipment Engineer
Dublin South
R&D Director
Galway
Manufacturing Engineer
Galway
Senior Product Development Engineer
Galway
Senior Product Development Engineer
Galway
Manufacturing Specialist - Investigation
Dublin
Quality Systems Manager
Dublin
Quality Manager
Dublin
Quality Engineer - Supplier
Galway
Senior R&D Manager - Lifecycle Manag
Galway
Project Engineer
Roscommon
Senior R&D Engineer
Galway
Project Manager
Kildare
Sr Project Manager - Syringe Fill Engine
Dublin
Quality Manager
Galway
R&D Director
Galway
Principal Device Engineer
Dublin
Senior Reg Affairs Specialist - Post Mar
Galway
Senior Process Engineer - DP or DS
Dublin
Principal Engineer
Dublin
Equipment Engineer (Syringe Inspection S
Dublin
Business Manager (Critical Care & Me
Dublin
R&D Manager
Connaught
Project Engineer
Cork
Senior Maintenance Technician
Kilkenny
Quality Specialist
Clare
Senior Regulatory Affairs Specialist
Athlone
QA Manager
Canada
Technical Transfer Specialist - Remote
Republic of Ireland
Senior R&D Engineer
Galway
Senior Production Supervisor
Galway City
R&D Manager
Connaught
R&D Manager
Galway
Senior Manufacturing Specialist
Dublin
CTO
Dublin
Project Manager
Galway
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 NPI Engineer - Hybrid


Reference:SMC39508 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Process Engineer

We’re currently recruiting for an exciting opportunity with a 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

  • Development of validation plans, process performance qualifications for vial and syringe filling.
  • Ensuring all aspects of activity within any given process validation adheres to required policies and procedures, including safety and training.
  • Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer.
  • Participate in process validation cross functional teams at the site to ensure adherence to required policies and procedures and be responsible to deliver against organizational goals and project milestones.
  • Pre-approve and post-approve process validation protocols and assessments from a quality system documentation perspective.
  • Actively communicates across functions and sites and is a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions.
  • Act as the responsible point contact from ADL site for the transfer project for drug product teams.
  • Assist in the development of any existing validation program to ensure continued compliance to the necessary regulations and input to site validation guidance documents.
  • Collate and report on relevant shipping and filter validation.
  • Assist in deviation and exception resolution and root cause analysis.
  • Contribute to product quality assessments and process flow documents.
  • Lead Continuous Improvement initiatives for the NPI team

Education & Experience
  • 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.
  • 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 protein freeze-thawing, filtration, mixing, filling (PpK / batch homogeneity) and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability.
  • Project management skills including the ability to manage multiple projects and evaluate project resource requirements.
  • Strong knowledge of Quality systems, Drug Product Manufacturing and Validation.
  • Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skills are essential for this role.

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