Skip to main content

Contract Validation Engineer

  1. Ireland, West
Galway
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
36615

This vacancy has now expired

Contract Validation Engineer - Ireland - 9 Months Contract

Are you looking for the opportunity to work alongside a global pharmaceutical organisation in Ireland? Our esteemed client is looking for a Contract Validation Engineer to join their team in their existing manufacturing facility in Ireland.

The facility is a responsible for tablet manufacturing (OSD) and secondary packaging (blister packing and bottle primarily for tablets and capsules), and our client is looking for an Contract Validation Engineer to help maintain manufacturing operations.

Responsibilities:
  • Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for sterile manufacturing equipment.
  • Ensure compliance with cGMP, FDA, EMA, and Annex 1 requirements for validation activities.
  • Perform risk assessments (e.g., FMEA) to determine validation strategies and critical parameters.
  • Maintain the validated state of manufacturing equipment, clean utilities, and process support systems.
  • Qualify and validate aseptic filling lines, lyophilizers, autoclaves, depyrogenation tunnels, and isolator/RABS systems.
  • Support clean utilities qualification (e.g., WFI, clean steam, compressed air, HVAC).
  • Ensure validation of automation and control systems (SCADA, PLC, MES) where applicable.
  • Author and review validation documentation, including Validation Master Plans (VMP), protocols, and reports.
  • Support audits and regulatory inspections by providing validation data and technical justifications.
  • Ensure adherence to Annex 1, ICH Q9 (Risk Management), ICH Q10 (Quality Systems), and FDA Process Validation Guidance.
Requirements:
  • Education: Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Biomedical, or related field) or Life Sciences.
  • Extensive experience in validation, equipment qualification, or technical services within sterile injectables manufacturing.
  • Expertise in IQ/OQ/PQ for aseptic processing equipment and utilities.
  • Strong understanding of cGMP, FDA, EMA, and Annex 1 guidelines.
  • Experience with validation life cycle approach (URS, FAT/SAT, PQ).
  • Knowledge of data integrity (ALCOA+ principles) and computerised system validation (CSV).
  • Familiarity with environmental monitoring systems and clean-room qualification.
  • Strong analytical and problem-solving skills.
  • Excellent documentation and technical writing abilities.
  • Effective communication and cross-functional collaboration.
If this role is of interest to you, please apply now!
 #LI-CY2

Save as a job alert
List #1

Similar Jobs

Validation Specialist

Salary

Competitive

Location

Oxford

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

England

South East

Description

Validation Specialist - UK, Oxford - 11 Month Contract Are you a Validation Specialist professional with experience in Oxford? Are you looking to take the next step in your career and be part of

Reference

37530

Expiry Date

01/01/0001

Charlie Yearley Read more
Commissioning & Qualification Manager

Salary

Competitive

Location

Paris

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

France

Description

Commissioning & Qualification Manager - France, Paris - 12 Months Contract Do you want to work at a leading global pharmaceutical manufacturer? If so, this is the assignment for you! Our global

Reference

37588

Expiry Date

01/01/0001

Farhan Younas

Author

Farhan Younas
Read more
Operational Readiness Program Manager

Salary

Competitive

Location

Ohio

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

North America

East Coast

Description

Operational Readiness Program Manager - Ohio - 12-mont initial contract -  Life Sciences  This is a fantastic opportunity for an Operational Readiness Program Manager to join our major, global

Reference

37580

Expiry Date

01/01/0001

Annabel Nangle Read more

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.