Browse by job sector

Senior C&V Process Upstream Engineer

  1. Brussels
Brussels
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
34574nr
Apply to this job Save job
Senior C&V Process Upstream Engineer - Brussels, Belgium - 12-Month Contract 

We are looking for an experienced Senior C&V Process Upstream Engineer for a fantastic 12 month contract based in Brussels.

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:
  • Accountable for the team Drafting or support the document drafting by a partner or supplier, coordinate review and approval of applicable C&Q documents (QRA/DV/RTM/FAT/SAT/IOV/VSR) following approved VMP and SLIA.
  • Act as C&Q Subject Matter Expert and Compliance. Ability to provide guidance/ manage supplier and all C&Q activities for the system(s), from design to field execution and to summary report approval.
  • Drive verification testing, protocol execution, walk-downs, verification of system drawings, design and operational testing and troubleshoot as required. Conduct deviation investigation and resolution for problems and issues encountered during field execution activities.
  • 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.
  • Accountable for the Review and acceptance by the team of turnover of equipment / system from construction group. Ensures Start-up of equipment/ system is completed in a safe and coordinated manner.
  • Generate and or review change controls related to C&Q and drive their closure in a timely manner
  • Ensures all personnel who perform C&Q activities for the system(s) have relevant training assigned.
  • Assist/ facilitate in the development of User Requirement Specifications (URS's) and Quality Risk Assessment for Equipment and Systems in scope.
 
Requirements:
  • 5+ years of hands-on, end to end experience with this equipment in International CAPEX C&Q
  • Extensive knowledge and demonstrated experience delivering Commissioning and Qualification for Pharmaceutical / Biotechnology projects including automation related aspects of equipment.
  • Experience with Post OQ activities is preferred.
  • Experience of sterile / biotech / single use equipment in the bio-pharmaceutical industry is preferred.
  • Experience with ISPE best practice / GAMP-5/ Anex 15 GMP EU/ ASTM E2500/ electronic execution
  • Knowledge of safety, GMP and environmental regulatory requirements
  • Be willing to Travel for FAT/SAT

 If this role is of interest to you, please apply now! 


 #LI-CB1
Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Senior Project Manager

Salary

Competitive

Location

Frankfurt ( Oder)

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

Central Germany

Description

Snr Project Manager  - Pharmaceuticals - Frankfurt - 3-Year Contract  We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Snr Project Manager. Due

Reference

34402

Expiry Date

01/01/0001

Amy Baxter

Author

Amy Baxter
Amy Baxter

Author

Amy Baxter
Read more
Read more
Engineering Director

Salary

Competitive

Location

Berlin

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

Central Germany

Description

Engineering Director  - Pharmaceuticals - Frankfurt - 3-Year Contract  We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Engineering Director.

Reference

32146

Expiry Date

01/01/0001

Amy Baxter

Author

Amy Baxter
Amy Baxter

Author

Amy Baxter
Read more
Read more
Engineering Director

Salary

Competitive

Location

Berlin

Salary

Competitive

Sector

Commissioning, Qualification and Validation

Job type

Contract

Location

Central Germany

Description

Engineering Director  - Pharmaceuticals - Frankfurt - 3-Year Contract  We are recruiting on behalf of a leading global pharmaceutical client based in the surroundings of Engineering Director.

Reference

32151

Expiry Date

01/01/0001

Amy Baxter

Author

Amy Baxter
Amy Baxter

Author

Amy Baxter
Read more
Read more

Insights

Day In the Life of a Commissioning Engineer

Day in the Life of a Commissioning Engineer

Read more

11/03/2023

life sciences testing laboratory

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

02/07/2023

engineer in white hard hat operating machinery

What is a Commissioning Engineer and why you should become one
Read more

01/26/2023

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