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
Senior R&D Engineer
Galway
Industrial Designer
Galway
EHS Specialist II
Limerick
Laboratory Systems Specialist
Meath
R&D Manager
Connaught
QC Microbiology Technician
Kildare
Production Manager
Dublin
Application Software Engineer
Galway
Senior R&D Engineer
Dublin
Senior Quality Assurance Engineer
Galway
Senior R&D Manager
Athlone
Validation Engineer
Athlone
CTO
Dublin
Director of Quality Engineering
Limerick
Design Assurance Program Manager
Galway
Senior Quality Assurance Technical Suppo
Dublin
Senior Design Assurance Engineer
Galway
R&D Manager
Connaught
Senior Process Engineer - Packaging
Dublin
Business Development Manager
Republic of Ireland
R&D Engineer
Galway
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Quality Engineer
Dublin
Senior Regulatory Affairs
Galway
QA Engineer
Leitrim
Principal Process Equipment Engineer
Dublin South
Health & Safety Specialist
Dublin
R&D Manager
Galway
Senior Quality Engineer
Leitrim
Injection Molding Engineer
Mayo
Quality Manager
Galway
A.I Specialist
Clare
Territory Manager (Endoscopy)
Dublin
Laboratory Technician (Microbiology &
Dublin
Senior QC Specialist - Equipment & I
Dublin
Senior Electronic Engineer
Dublin
Product Development Engineer II
Athlone
Quality Assurance Senior Specialist
Louth
Principal R&D Engineer
Dublin
R&D Director
Galway
Senior Sterile Drug Product MSAT Consult
Republic of Ireland
Senior Regulatory Affairs Specialist
Athlone
Senior Maintenance Technician
Kilkenny
Design Assurance Manager
Galway
Senior Scientific Officer
Dublin
Process Chemist
Limerick
Quality Manager
Galway
Analytical Chemist
Tipperary
Regulatory Affairs Manager - Senior
Galway
Process Engineer
Galway
R&D Manager
Galway
A.I Specialist
Clare
Production Manager
Wexford
Senior Quality Engineer
Dublin
EHSS Specialist
Athlone
R&D Engineer
Dublin
Project Engineer
Roscommon
Manufacturing Engineer
Galway
Senior Engineering Manager
Galway
Director of R&D
Galway
Inside Scientific Sales Specialist
Dublin
Staff Systems Engineer
Limerick
R&D Manager
Connaught
Senior QC Analyst
Republic of Ireland
Senior Production Manager
Cork
Process Development Engineer
Galway
Senior Project Engineer
Cavan
Quality Engineer
Athlone
Design Assurance Engineer
Galway
EAP Program Manager
Republic of Ireland
Industrial Engineer Capacity Planning
Dublin
A.I Specialist
Galway
Director of R&D
Limerick
Senior Equipment Engineer
Dublin
R&D Manager
Connaught
Manufacturing Technician
Clare
Senior Equipment Design Engineer
Dublin
Senior Clinical Data Analyst
Dublin
Quality Engineer
Athlone
Senior R&D Engineer
Galway
Principal Reliability Engineer
Galway
Senior Design Assurance Engineer
Galway
Senior Specialist MS&T
Dublin
Senior R&D Engineer
Galway
QA Manager
Canada
EHSS Specialist (Construction & Comm
Athlone
Senior Regulatory Affairs Specialist
Athlone
Senior Engineering Manager
Limerick
Quality Specialist
Clare
Senior Reg Affairs Specialist - Post Mar
Galway
R&D Senior Program Manager
Galway
Senior Quality Engineer
Galway
Senior Regulatroy Affairs Specialsit
Galway
Website Audit Specialist
Dublin
Key Account Manager - Retail UK National
South East
Senior Quality Systems Engineer
Galway
R&D Engineer
Galway
Manufacturing Technician
Clare
R&D Manager
Athlone
Business Resilience Specialist
Dublin
Principal R&D Engineer
Galway
Senior Commissioning & Qualification
Roscommon
Product Specialist (Critical Care &
Dublin
Equipment Engineer (Syringe filling)
Dublin
R&D Engineer
Galway
Senior Process Development Engineer
Dublin
Senior Product Development Engineer
Galway
Senior Quality Engineer
Dublin
Clinical Trial Protocol Specialist
Galway
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Westmeath
Clinical Trial Protocol Specialist
Galway
Senior Clinical Engagement Project Manag
Dublin
R&D Engineer
Galway
CQV Engineer
Roscommon
Calibration Technician
Republic of Ireland
Product Development Manager
Galway
Project Engineer - Senior
Cavan
Senior Clinical Data Analyst
Dublin
Quality Technician
Dublin
Senior Regulatory Specialist
Cork
Product Development Engineer II
Athlone
Senior Manufacting Engineer
Republic of Ireland
Software Design Assurance Engineer
Dublin
Quality Control Analyst (Cell Culture)
Carlow
Senior Project Engineer
Cork
Senior Quality Engineer
Leitrim
Product Specialist (Critical Care &
Dublin
Senior Maintenance Technician
Kilkenny
R&D Engineer
Clare
Quality Control (QC) Technician
Kildare
Product Development Engineer II
Athlone
Senior QA Associate (shift)
Dublin
Injection Moulding Engineer
Athlone
Senior Electronic Engineer - Regulated M
Galway
Senior Electronic Engineer
Dublin
Senior Regulatory Affairs Specialist
Athlone
Senior Regulatory Affairs Specialist
Dublin
Senior Quality Engineer
Dublin
R&D Director
Galway
Product Specialist (Critical Care &
Dublin
Quality Specialist
Clare
R&D Engineer
Galway
R&D Engineer
Galway
Senior Regulatory Affairs Specialist
Clare
Quality Engineer
Galway
Senior Maintenance Technician
Roscommon
Tech Transfer Lead
Dublin
CTO
Galway
Sr Principal R&D Engineer
Galway
Mechanical Technician
Carlow
R&D Engineer
Galway
Bioinformatician
Dublin
Principal R&D Engineer
Dublin
Senior Engineering Manager
Galway
Senior R&D Engineer
Dublin
Technical Life Cycle & Engineering M
Galway
Project Manager
Kildare
Senior QC Microbiology
Dublin
UK Based-EAP Program Manager-Remote
United Kingdom
Design Assurance Engineer
Galway
Senior Principal Design and Development
Galway
Operations Engineer
Galway
Quality Assurance Specialist - Tech Tran
Dublin
Product Development Manager
Galway
Senior QC Microbiology
Dublin
Advanced Technologies Manager
Galway
Quality Assurance Manager
Galway
Validation Engineer
Dublin
Marketing Manager
Galway
Validation Engineer Intermediate
Dublin
Project Manager
Galway
Quality Engineer
Galway
Product Development Engineer
Galway
Process Engineer - Sterile Drug Product
Waterford
R&D Manager
Dublin
Regulatory Affairs Maanger
Galway
Embedded Software Engineer
Dublin
Principal R&D Engineer
Galway
Senior Client Side Design Manager
Westmeath
Production Operator
Meath
Senior Operational Readiness Associate
Dublin
Quality Systems Manager
Dublin
R&D Engineer
Dublin
Design Assurance Engineer
Galway
Manufacturing Technician
Clare
Senior Operations Engineer
Galway
Project Manager
Kildare
Senior Design Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior Research and Development Engineer
Galway
Quality and Regulatory Affairs Manager
Dublin
QA Deviations Specialist
Dublin
Advanced Technologies R&D Manager
Clare
Regulatory Affairs Specialist
Cork
Senior Project Manager - Contract Develo
Dublin
Documentation Specialist
Louth
LIMS Specialist
Tipperary
R&D Technician II
Galway
Senior R&D Engineer
Galway
Quality Engineer - Supplier
Galway
Process Engineer
Leitrim
Senior Regulatory Affairs Manager
Galway
Operations Lead
Dublin
Lead MSAT Validation Consultant
Republic of Ireland
Senior Electronics Engineer
Dublin
R&D Manager
Galway
Business Development Manager (Hospitals)
Cork
Senior Manufacturing Engineer
Galway
Principal R&D Engineer
Galway
Product Development Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Lead Mechanical Design Engineer
Limerick
R&D Manager
Galway
Head of Digital & Technology
Dublin
Electronic Engineering
Dublin
Senior R&D Engineer
Dublin
R&D Manager
Athlone
Quality Specialist
Tipperary
Quality Assurance Specialist
Waterford
Senior Design Assurance Engineer
Galway
(Senior) Manufacturing Engineers - Globa
Limerick
Head of Data Partnerships & Operatio
Dublin
Senior R&D Engineer
Galway
Injection Moulding Engineer
Athlone
Responsible Person (RP)
Republic of Ireland
Senior Quality Engineer
Galway
Senior Director of Manufacturing and Sup
Galway
R&D Manager
Galway
Senior Quality Assurance Associate
Dublin
Product Development Technician II
Galway
Quality Technician
Galway
R&D Engineer
Galway
Quality Assurance Specialist/Manager
Dublin
Documentation Specialist
Louth
R&D Director
Galway
Clinical Advisor - Wound care (Part-time
Dublin
Clinical Applications Specialist (Surgic
Belfast City
Engineering Business Manager
Dublin
Quality Engineer - Supplier
Galway
Senior Quality Engineer
Leitrim
Principal Engineer
Dublin
Project Manager (hybrid)
Dublin
Quality Assurance Engineer
Longford
Pharmacovigilance Manager (Remote)
Republic of Ireland
Senior Manufacturing Engineer
Cork
Senior Operations Engineer
Galway
Design Assurance Engineer
Galway
Tech Transfer Lead - Sterile Drug Produc
Dublin
Principal R&D Engineer
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.