Browse by job sector

Senior Validation Engineer

  1. Belgium, Brussels
Brussels
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
36734

This vacancy has now expired

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 with our client who are a global biopharmaceutical organisation committed to improving the lives of people afflicted with neurological and immunological disease.

This is a superb opportunity if you are looking to advance your career in the field with a supportive and innovative company that will put you first.

Responsibilities:
  • Act as C&Q Subject Matter Expert and Compliance for PQ. Ability to provide guidance and work with project stakeholders (technical, QA, validation, QC) and suppliers in all PQ activities from strategy development to PQ protocol and acceptance criteria definition and execution and to summary report approval. to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities’ expectations and related SOPs.
  • Draft PQ strategy/protocol(s) and testing rationals following approved PQ VMP, collect input from stakeholders, coordinate review and approval cycle in a timely manner.
  • Assist/ facilitate in the development of specific Quality Risk Assessment for PQ.
  • Drive PQ verification deliverables, cycle development, protocol execution, deviation investigation and resolution for problems and issues encountered during execution activities.
  • Write and coordinate approval of change controls related to technical modifications.
  • Responsible for the Planning, Tracking and Reporting of C&Q status and risks/issues for the selected system(s). Take appropriate corrective actions as required to ensure deadlines and milestones are achieved.
Requirements:
  • Degree in relevant field, Engineering etc
  • Extensive years of hands-on, end to end experiencewith PQ phase having led and managed validation projects, including sterile manufacturing. Ideally also experience in manufacturing / manufacturing science and/or technology / technical development / quality.
  • Deep understanding and experience of all PQ verification strategy and testing.
  • Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry. Experience with ISPE best practice / GAMP-5/ Anex 15 GMP EU/ ASTM E2500/ electronic execution.
  • Extensive knowledge and experience with Process Performance testing: Mock-up, Media Simulation, Media Fill, Engineering runs is preferred. Expert in all Biotech process, in DS/DP and ideally in Gene therapy rAAV.
  • Extensive knowledge and demonstrated experience delivering Commissioning and Qualification for single use for Pharmaceutical / Biotechnology projects including automation related aspects of equipment is preferred.
  • Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
  • Expert in reviewing and writing technical reports.
If this role is of interest to you, please apply now!
 #LI-CB1


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

West

Description

Validation Engineer - Ireland - 11 Months Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines, our

Reference

36688

Expiry Date

01/01/0001

Christopher Hutchinson

Author

Christopher Hutchinson
Christopher Hutchinson

Author

Christopher Hutchinson
Read more
Read more
Commissioning & Qualification Lead

Salary

Competitive

Location

Lille

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

France

Description

Commissioning & Qualification Lead - France, Lille - 6 Months Initial Contract How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If

Reference

 37617

Expiry Date

01/01/0001

Suraj Chauhan

Author

Suraj Chauhan
Suraj Chauhan

Author

Suraj Chauhan
Read more
Read more
QA Validation Engineer

Salary

Competitive

Location

Swindon

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

England

South West

Description

QA Validation Engineer - UK, Swindon - 3-6 Months Contract Our client is a leader in helping address some of the world’s biggest science, health, and environmental challenges. The company works

Reference

37611

Expiry Date

01/01/0001

Chris Bland

Author

Chris Bland
Chris Bland

Author

Chris Bland
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