Browse by job sector

CQV Lead

  1. East Coast
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
06-05-2021
26365

This vacancy has now expired

CQV Lead Drug Substance Upstream & Downstream - Global Biopharmaceutical Client - USA

Our client is making a significant capital investment for a new biologics facility in the USA and requires a CQV Lead to work on the multi-billion-dollar project.

The Role:
  • CQV Lead Engineer for all Upstream & Downstream systems (Inoc, Media, Cell Culture, Harvest, UF-DF-Depth Filter-Viral Filter-Chromo-Purification-etc), initially responsible for timely review and approval of all CQV documentation, including but not limited to – EDR-DQ, SIA, FAT, RTM, QRA, RV, SAT, IOC, IOQ and Final Reports.
  • Review of all Design deliverables from EPCM, including Drawings, Datasheets, specifications and Engineering Lists. Also assist in GMP reviews. Author all CQV sub plans (VPP) for Upstream/Downstream Areas. Review of all GMP generated documentation via the KNEAT system.
  • Liaise with the CMMS Team from day 1 to ensure timely transition of GMP information into the CMMS system.
  • Aligning with EPCM and CQV Turnover Lead in relation to System boundaries and Lead and review exercise.
  • Point CQV person for Vendor review for all Upstream/Downstream Vendor Packages.
  • CQV SME for all Upstream/Downstream Systems.
  • Liaise with EPCM in relation to construction readiness and a schedule for all Upstream/Downstream   systems.  Lead CQV effort for schedule review and readiness.  Also perform and lead all field walk-downs for all Upstream/Downstream systems.
  • Lead CQV review, aligning with Transition Group in relation to review and approval of all Turnover Packages, both Vendor and Contractor Packages within the Upstream/Downstream Areas. 
  • Liaise with CQV SWAT Team in relation to punchlist closure both pre-M/C and during the CQV execution phase for Upstream/Downstream Systems. 
  • Liaise with CQV PM and Lead Scheduler in relation to schedule creation and management for all Upstream/Downstream Systems, ensuring all correct predecessors and successors are in place.
  • Ensure Commissioning readiness of all Upstream/Downstream Systems to support Equipment Start-up and IOC-IOQ Testing.
  • Lead PSSR/STW field execution and guide CQV Team through Start-up exercise in a safe and controlled manner.
  • Liaise with all Project Groups (Design/CM/CQV/Automation/Process/SMEs/Ops/Maintenance/PMs) to ensure all Upstream/Downstream Systems are managed appropriately for the entire Project Lifecycle.
  • Lead execution of all Upstream/Downstream CQV deliverables; FAT/SAT/CTP/IOQ.
  • Generate and ensure timely approval of all Commissioning and IOQ Final Reports.
 
If this role interests you, apply today.

 



The candidate must have the rights to work in the location stated in the job advert.

Please note, Quanta part of QCS Staffing does not sponsor Visa applications.

To view Quanta's privacy policy, please visit our website
Save as a job alert
List #1

Similar Jobs

CMMS Engineer

Salary

Competitive

Location

County Dublin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Dublin

Description

CMMS Engineer - Pharmaceuticals - Dublin - 9-Months  Would you like to grow your career, whilst contributing to scientific innovations that are transforming patients’ lives? Our client, a

Reference

33743

Expiry Date

01/01/0001

James Smithson

Author

James Smithson
James Smithson

Author

James Smithson
Read more
Read more
Automation Engineer

Salary

Competitive

Location

County Dublin

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Dublin

Description

VPE Automation Engineer - Dublin, Ireland - 12-Month Contract  Do you want to work with an exciting company who are an established market leader within their niche field? We have a fantastic

Reference

33582

Expiry Date

01/01/0001

Finn Bannon

Author

Finn Bannon
Finn Bannon

Author

Finn Bannon
Read more
Read more
Technical Specialist - Microbiology

Salary

Competitive

Location

Cork

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

East Anglia

Description

Technical Specialist - Microbiology - Pharmaceuticals - 12-Month Contract  One of our global Pharmaceutical clients is looking for a Technical Specialist to join their team close to the

Reference

33422

Expiry Date

01/01/0001

Jack Steadman

Author

Jack Steadman
Jack Steadman

Author

Jack Steadman
Read more
Read more

Insights

life sciences testing laboratory

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

02/07/2023

Your next step as a Validation Engineer
Read more

07/20/2021

pharmaceutical factory construction

Working in an organisation from Start Up Phase

Read more

06/28/2021

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