Browse by job sector

IV CQV Engineer

  1. North America, United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
34821

This vacancy has now expired

IV CQV Engineer - Pharma - 12-Month Contract 

Our client is a large CDMO that specializes in cell culture and gene therapy. We are currently looking for a CQV IV Engineer with hands-on background in biotech and greenfield projects. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.


Main Duties
  • Reviewing turnover packages from vendors and construction
  • Walking systems to ensure installation is correct (knows how to walk and read P&IDs)
  • Is able to operate independently after given direction on what to do
  • Ensure IV execution is carried out in accordance with engineering specifications, CQV procedures, CQV project strategies, and industry standards such as BPE commissioning and validation guidelines.
  • Liaise with Jacobs and FDBN in relation to quality of construction documentation intended to leverage for qualification.
  • Align with CQV Turnover in relation to review and approval of all Turnover Packages, both VTOPs and CTOPs.
  • Liaise with CQV SWAT Team in relation to punchlist closure both pre-MC and during the CQV execution phase for all systems in relation to IV execution.
  • Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Systems requiring IV execution are managed appropriately.
  • Liaise with System Owners (Responsible Engineers) for IV tasks, including but not limited to specification deviation requests, PCC impact to test cases, and vendor documentation gaps.
  • Coordinate timelines and needs for required IV pre-req documents, including but not limited to VDRs for IV execution, VDRs for OV execution start, QAM reports, CTOP test pack deliverables, and passivation and pressure test documentation from vendors, CMT, and STW activities


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

 #LI-MC1
Save as a job alert
List #1

Similar Jobs

Senior Project Manager

Salary

Competitive

Location

Dublin

Salary

Competitive

Sector

CAPEX Projects

Compliance / Quality Assurance

Job type

Contract

Location

Ireland

Dublin

Description

Senior Project Manager  - Ireland, Dublin - 6-12 Month Contract How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If yes, then this

Reference

37207D

Expiry Date

01/01/0001

Suraj Chauhan

Author

Suraj Chauhan
Suraj Chauhan

Author

Suraj Chauhan
Read more
Read more
Project Coordinator

Salary

Competitive

Location

Sligo

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

West

Description

Project Coordinator - Ireland, Sligo - 12 Month Contract  Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for a Project Coordinator to join their

Reference

37205

Expiry Date

01/01/0001

James Smithson

Author

James Smithson
James Smithson

Author

James Smithson
Read more
Read more
Manufacturing Bioprocess Associate

Salary

Competitive

Location

County Dublin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

Dublin

Description

Manufacturing Bioprocess Associate - Dublin, Ireland - 11 Months Contract This is a fantastic opportunity to be part of a fast-paced, €400 million project; with lots of opportunities to work

Reference

36386

Expiry Date

01/01/0001

Dawn Hosier

Author

Dawn Hosier
Dawn Hosier

Author

Dawn Hosier
Read more
Read more

Insights

North Carolina

Living and working in North Carolina
Read more

03/26/2024

Living and Working in Michigan

Living and Working in Michigan
Read more

10/25/2023

Living and Working in Chicago

Living and Working in Chicago

Read more

08/18/2023

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