Browse by job sector

CQV Lead

  1. North America, United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
36398
Apply to this job Save job
CQV Lead - North Carolina - 12 Months Contract

Our client, a globally recognized pioneer in Biotechnology, are recruiting for the position of CQV Lead. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. The project at hand is for the construction of a new build biomanufacturing plant based located on the East Coast.

Essential duties and responsibilities for this role include, but are not limited to, the following:
  • Develop and implement the CQV strategy for a $1 billion greenfield project, ensuring compliance with regulatory and operational requirements for equipment in one of the following areas: Upstream, Downstream, Buffers, Media Prep,Purification, Clean Utilities, and Black Utilities.
  • Lead the full CQV lifecycle, from early design phases through execution, qualification, and operational readiness.
  • Define the CQV strategy, including risk-based approaches, qualification requirements, and validation master plans.
  • Build and lead a high-performing CQV team, overseeing staffing, resource allocation, and performance management.
  • Utilize Kneat for digital validation and documentation management.
  • Ensure alignment with industry regulations, company policies, and best practices in commissioning and validation.
  • Collaborate closely with engineering, construction, and manufacturing teams to ensure smooth integration of CQV activities.
  • Drive project execution, maintaining timelines, budgets, and quality expectations.
Desirable Experience:
  • Extensive experience in CQV project management within the biopharmaceutical or life sciences industry.
  • Proven experience leading CQV efforts for large-scale greenfield drug substance projects ($500M+).
  • End-to-end project delivery experience, from design through operational handover.
  • Expertise in defining and executing CQV strategies for complex manufacturing facilities.
  • Kneat expertise is required.
If this role is of interest, please apply now.
 #LI-DA1

Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Senior Buyer

Salary

Competitive

Location

Cork

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

Cork

Description

Senior Buyer - Cork, Ireland - 12 Months  Are you interested in joining a world leading biopharmaceutical company, focused on developing advanced and innovative treatments for those suffering with

Reference

36610

Expiry Date

01/01/0001

Katarina Chalanska

Author

Katarina Chalanska
Katarina Chalanska

Author

Katarina Chalanska
Read more
Read more
CQV Project Coordinator

Salary

Competitive

Location

North Carolina

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

East Coast

Description

CQV Project Coordinator - US, North Carolina - 6-12 Months Contract    This is a fantastic opportunity for a CQV Project Coordinator  to join our major, global pharmaceutical client on their

Reference

36934

Expiry Date

01/01/0001

Mark Chaumeton

Author

Mark Chaumeton
Mark Chaumeton

Author

Mark Chaumeton
Read more
Read more
QC Systems Specialist

Salary

Competitive

Location

Ireland

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Ireland

Dublin

Description

QC Systems Specialist - Ireland - 6-12 Months Contract  Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of veterinary vaccines,

Reference

36932

Expiry Date

01/01/0001

Christopher Hutchinson

Author

Christopher Hutchinson
Christopher Hutchinson

Author

Christopher Hutchinson
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