Browse by job sector

Process Validation Engineer

  1. Ireland, Cork
Cork
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
36640
Apply to this job Save job
Process Validation Engineer, Drug Substance - Cork, Ireland - 12 Months Contract

Are you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for those suffering with rare diseases?

This is a fantastic opportunity to work in a state-of-the-art facility in Cork. You will be joining a leading Biopharmaceutical company who focus on a range of products which are life-changing for individuals.

Our client is currently seeking Process Validation Engineer - Drug Substance

Responsibilities include:
  • Perform process validation activities related to Client’s drug substance and drug products, through defined clinical and commercial stages.
  • Execute (protocol generation, execution, and final package preparation) process validation activities related to the implementation of process changes and new processes while exercising supervised judgement within broadly defined procedures and practices to establish acceptance criteria, and to identify and implement solutions to meet Client’s and Health Authority requirements.
  • Assist with preparation of regulatory filings, with answering questions from regulatory agencies, and with presentations of materials during regulatory inspections/partner audits.
  • Development and implementation of SOPs/Guideline documents with systemic procedural improvements.
  • Determine methods and procedures on new assignments with supervision and in accordance with developed practices and procedures. 
  • May participate on sub-teams.
  • Gain/maintain knowledge of industry standards and regulatory requirements for products developed and manufactured by the Client, validation techniques/approaches and systems utilised by the Client.
Requirements:
  • Experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in process validation, process sciences and change control.
  • Experience in a position utilising formal project management a plus.
  • Organisational and management skills to participate in multi-discipline project groups
  • Ability to communicate with, present data to, and defend approaches in front of variable hierarchical audiences, scientific disciplines and health authority reviewers/inspectorate.
  • Ability to comprehend scientific/technical information related to equipment, processes, and regulatory expectations.
  • Understanding and demonstrated knowledge of regulatory requirements, guidelines, and recommendations for process validation expectations. 
If this role is of interest, please apply now!

 #LI-JS5

 



Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Validation Engineer

Salary

Competitive

Location

Carlow

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

Ireland

Dublin

Description

Validation Engineer – Ireland – Pharmaceuticals – Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary

Reference

36644

Expiry Date

01/01/0001

Christopher Hutchinson

Author

Christopher Hutchinson
Christopher Hutchinson

Author

Christopher Hutchinson
Read more
Read more
Commissioning Manager

Salary

Competitive

Location

Central London

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

England

London

Description

Commissioning Manager - UK, London - 12 Month Contract Our client designs, constructs and operates some of Europe’s most efficient data centres, with pioneering the use of free air-cooling,

Reference

37390

Expiry Date

01/01/0001

Iain Dickens

Author

Iain Dickens
Iain Dickens

Author

Iain Dickens
Read more
Read more
Regional Commissioning Lead

Salary

Competitive

Location

Vienna

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Permanent

Location

Austria

Vienna

Description

Regional Commissioning Lead  - Austria, Vienna - Permanent Contract  Are you a Regional Commissioning Lead looking for your next contract role? We have a fantastic opportunity for you to join

Reference

37029A

Expiry Date

01/01/0001

Gary Bartholomew

Author

Gary Bartholomew
Gary Bartholomew

Author

Gary Bartholomew
Read more
Read more

Insights

QCS Staffing Validation Engineer Jobs: In-Demand Skills and Career Paths

Validation Engineer Jobs: In-Demand Skills and Career Paths
Read more

05/27/2025

Day In the Life of a Commissioning Engineer Jobs

Day in the Life of a Commissioning Engineer

Read more

11/03/2024

life sciences testing laboratory

Why you should work in Commissioning, Qualification and Validation
Read more

02/07/2023

VIEW ALL

Send us your CV

Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.

Send your CV
Upload your CV