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 Lead

Salary

Competitive

Location

Bielefeld

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

Germany

Central Germany

Description

Validation Lead - North Rhine-Westphalia, Norway - 6-12 Months Contract This innovative organisation is a global leader in the development and manufacturing of high-quality sterile injectable

Reference

36754

Expiry Date

01/01/0001

Peter Hallam

Author

Peter Hallam
Peter Hallam

Author

Peter Hallam
Read more
Read more
CQV DSM Engineer

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

North America

East Coast

Description

CQV DSM Engineer - Life Sciences - 6-month contract role - North Carolina  Our client, a global pharmaceutical manufacturing organization are looking for a talented CQV DSM Engineer to join their

Reference

36636MC

Expiry Date

01/01/0001

Mark Chaumeton

Author

Mark Chaumeton
Mark Chaumeton

Author

Mark Chaumeton
Read more
Read more
Senior Validation Engineer

Salary

Competitive

Location

Brussels

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

Belgium

Brussels

Description

Senior Validation Engineer  - Belgium - 9 Months Contract We are looking for an experienced Senior Validation Engineer for a fantastic 9 month contract based in belgium. You will be working

Reference

36734

Expiry Date

01/01/0001

Chris Bland

Author

Chris Bland
Chris Bland

Author

Chris Bland
Read more
Read more

Insights

Living and working in Ireland
Read more

03/12/2025

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