Browse by job sector

CQV Documentation Engineer

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. Life Sciences
37622
Apply to this job Save job
CQV Documentation Engineer - US, North Carolina

Our client, a global pharmaceutical manufacturing organisation are looking for a talented X to join their expanding team. 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.

Responsibilities:
  • Ability to read and understand CQV and site quality procedures and align with FDB Large Scale Biologics operating principles and regulatory requirements.
  • You will have the responsibility for closing out CQV teams, IV/ OV protocols along with working closely with QA to close out IQ/OQ summaries
  • Ability to work with an electronic validation system such as KNEAT or similar systems.
  • Conduct GDP reviews of test protocols pre and post execution to facilitate a timely review and approval process with Quality.
  • Utilize and own GDP checklist to track errors found in protocols and other documents. Update checklist as needed to ensure comprehensive list of potential GDP errors.
  • Conduct general documentation reviews of specifications, design documents, procedures, work instructions, etc. to ensure GDP requirements are met and standard formatting is maintained.
  • Liaise with CQV Leads, CQV Engineers and other departments to resolve GDP errors in protocols and documents.
  • Drive timely protocol closure for each phase of CQV.
  • Track and report weekly protocol closures.
  • Train CQV teams on GDP standards.
Requirements:
  • Requires extensive experience in a similar documentation review and/or Quality Assurance role for cGMP Documentation.
  • Prior experience with cGMP or in other highly regulated industries such as on Large Scale Projects and/or GMP operational facility.
  • Experience with liaising with other departments and engineers/QA, ensuring streamlined implementation of documentation review process or similar type process.
  • Willingness to step in a proactive manner for driving progress
  • Strong communication skills and ability to escalate issues as needed.
  • BA/BS in a related field and strong experience successfully executing complex projects in a Pharma/cGMP environment.
  • Emphasis for this hire is on attitude (Positive Can-Do attitude) and strong collaboration.
  • Acts with detail-driven ownership and follow through.

If you are interested, please apply now for immediate consideration and further information.

#LI-MC1

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

Similar Jobs

CQV Engineer

Salary

Competitive

Location

Toulouse

Salary

Competitive

Sector

Life Sciences

Job type

Contract

Location

France

Description

CQV Engineer - France, Toulouse - 4 Months Initial Contract Our client, a global biotechnology organisation, is recruiting for a CQV Engineer to join their capital project in Toulouse. This new

Reference

38134

Expiry Date

01/01/0001

Caroline O’Sullivan

Author

Caroline O’Sullivan
Caroline O’Sullivan

Author

Caroline O’Sullivan
Read more
Read more
Senior QA Specialist

Salary

Competitive

Location

Clonmel

Salary

Competitive

Sector

Compliance / Quality Assurance

Job type

Contract

Location

Ireland

Cork

Description

Senior Quality Assurance Specialist - Ireland, Clonmel - 11 Month Contract Do you want to be involved with exciting pharmaceutical projects? When it comes to the development and production of

Reference

38186

Expiry Date

01/01/0001

Tom Evans

Author

Tom Evans
Tom Evans

Author

Tom Evans
Read more
Read more
Planner

Salary

Competitive

Location

Louisiana

Salary

Competitive

Sector

Compliance / Quality Assurance

Job type

Contract

Location

North America

East Coast

Description

Planner (All Levels of Seniority) - US, Louisiana - 12 Month Contract This is a fantastic opportunity for a Planner (All Levels of Seniority) to join our major, global pharmaceutical client on

Reference

37257

Expiry Date

01/01/0001

Kristen Scott

Author

Kristen Scott
Kristen Scott

Author

Kristen Scott
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

QCS Staffing A Guide to Pharmacovigilance Careers

A Complete Guide to Pharmacovigilance Careers
Read more

05/15/2025

Living and working in Ireland
Read more

03/12/2025

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