Browse by job sector

CQV PQ Engineer

  1. North America, United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
36360

This vacancy has now expired

CQV PQ Engineer - North Carolina - 6 Months Rolling Contract 

Our client, a global pharmaceutical manufacturing organization are looking for a talented CQV PQ Engineer 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.

Essential Duties and Responsibilities for this role include, but are not limited to:
  • Plan and execute Process Qualification (PQ) activities for manufacturing processes to meet cGMP (current Good Manufacturing Practices) and regulatory requirements.
  • Lead the validation of downstream processes, including aseptic filling, purification, and formulation processes.
  • Conduct testing and evaluation of critical parameters such as temperature, pressure, and flow rates to ensure process consistency and reliability.
  • Oversee and manage stability holds during qualification and validation activities to ensure product integrity over time.
  • Collaborate with the stability team to implement testing schedules, analyze data, and ensure that the product maintains its required specifications throughout the stability period.
  • Ensure proper documentation and reporting of stability test results for regulatory submission.
  • Manage microbial holds to ensure microbial control during process validation and qualification activities.
  • Support microbiological testing and sterility assurance programs to validate aseptic processes.
  • Collaborate with the Microbiology and Quality Control teams to ensure microbial risk assessments are properly conducted and corrective actions are taken if necessary.
Requirements
  • Bachelor’s degree in Chemical Engineering, Biochemical Engineering, Biotechnology, or a related field. Master’s degree preferred.
  • Extensive experience in Process Qualification (PQ) within the biopharmaceutical, pharmaceutical, or life sciences industry.
  • Proven experience in managing stability holds, microbial holds, and aseptic filling process validation.
  • Experience with microbial contamination control, sterility assurance, and managing microbial risk.
  • Familiarity with regulatory requirements (FDA, EMA, ICH) and cGMP standards.
  • Hands-on experience with aseptic filling lines, including troubleshooting, qualification, and process monitoring.
  • Strong understanding of aseptic processing techniques, sterilization methods, and containment strategies.
If you are interested, please apply now for immediate consideration and further information.
 #LI-MC1
Save as a job alert
List #1

Similar Jobs

Project Technical Manager

Salary

Competitive

Location

Singapore

Salary

Competitive

Sector

CAPEX Projects

Job type

Permanent

Location

Singapore

Description

Project Technical Manager - Singapore - Permanent Contract  How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If yes, then this is

Reference

37557

Expiry Date

01/01/0001

Suraj Chauhan

Author

Suraj Chauhan
Suraj Chauhan

Author

Suraj Chauhan
Read more
Read more
Senior PM Tech Transfer

Salary

Competitive

Location

Oslo

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Norway

Description

Senior PM Tech Transfer - North of Oslo, Norway - 12 Months Contract We are recruiting for a rapidly growing CDMO located in North Oslo. Our client is seeking an exceptional Project Manager with

Reference

36748

Expiry Date

01/01/0001

Charlie Yearley

Author

Charlie Yearley
Charlie Yearley

Author

Charlie Yearley
Read more
Read more
Senior Construction Project Manager

Salary

Competitive

Location

Raleigh

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

North America

United States

Description

Senior Construction Project Manager - RTP, North Carolina - 12 Months Contract Our client, a globally recognized pioneer in Biotechnology, are recruiting for the position of Senior Construction

Reference

36313

Expiry Date

01/01/0001

Davis Atkinson

Author

Davis Atkinson
Davis Atkinson

Author

Davis Atkinson
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