Browse by job sector

CQV Temperature Mapping Engineer

  1. East Coast
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
34520
Apply to this job Save job
CQV Temperature Mapping Engineer - North Carolina - 12-Month Contract 

Our client, a global Pharmaceutical manufacturing organization are looking for a talented CQV Temperature Mapping 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.


Key Responsibilities:
  • Conduct temperature mapping studies for controlled environments including warehouses, cold rooms, freezers, incubators, and stability chambers.
  • Develop detailed temperature mapping protocols and reports following GMP (Good Manufacturing Practices) and regulatory requirements.
  • Utilize temperature monitoring equipment such as data loggers, thermocouples, and sensors to collect accurate temperature and humidity data.
  • Analyze temperature mapping data to ensure compliance with established acceptance criteria and regulatory standards.
  • Identify and troubleshoot any deviations or anomalies during temperature mapping studies.
  • Collaborate closely with cross-functional teams including Quality Assurance, Engineering, and Operations to ensure alignment of temperature mapping activities with overall project timelines.
  • Utilize kneat software for the management and execution of validation documentation, including protocols, reports, and traceability matrices.
  • Participate in risk assessments and contribute to the development of mitigation strategies related to temperature mapping.
  • Maintain accurate documentation and records of all temperature mapping activities in compliance with company procedures and regulatory requirements.
  • Stay updated with industry trends, regulatory changes, and best practices related to temperature mapping and CQV activities.

Qualifications:
  • Bachelor’s degree in Engineering, Science, Pharmacy, or related field.
  • years of experience in executing temperature mapping studies in a regulated environment, preferably in pharmaceuticals, biotechnology, or medical devices.
  • Strong knowledge of regulatory requirements such as FDA, EU GMP, and ICH guidelines pertaining to temperature mapping.
  • Experience with temperature mapping equipment and software (e.g., Kaye Validator, Vaisala, Sensitech).
  • Proficiency in using Kneat software for validation document management and execution.
  • Excellent analytical and problem-solving skills with the ability to interpret complex data sets.
  • Proven ability to work independently and as part of a team in a fast-paced environment.
  • Effective communication skills with the ability to present findings and recommendations clearly and concisely.

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

 #LI-MC1
Apply to this job Save job
Save as a job alert
List #1

Similar Jobs

Maintenance / Project engineer

Salary

Competitive

Location

Bedford

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

East Anglia

Description

Maintenance / Project Engineer -  Life Sciences - Bedford - 6-Months  How would you like the opportunity to work with in one of the largest biopharmaceutical projects in the country? If yes,

Reference

35167

Expiry Date

01/01/0001

Bobby Andrews

Author

Bobby Andrews
Bobby Andrews

Author

Bobby Andrews
Read more
Read more
Procurement

Salary

Competitive

Location

San Juan

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Argentina

Description

Procurement - Pharmaceuticals - San Juan - 12-Month Contract  This is a fantastic opportunity for a Procurement to join our major, global pharmaceutical client on their latest new-build project

Reference

35286

Expiry Date

01/01/0001

Kristen Scott

Author

Kristen Scott
Kristen Scott

Author

Kristen Scott
Read more
Read more
Quality Engineer

Salary

Competitive

Location

County Mayo

Salary

Competitive

Sector

CAPEX Projects

Job type

Contract

Location

Midlands (Ireland)

Description

Quality Engineer - Westport, County Mayo Located on the picturesque west coast of Ireland, our Global pharmaceutical client is looking for Quality Engineerto join their state of the art

Reference

34865

Expiry Date

01/01/0001

James Smithson

Author

James Smithson
James Smithson

Author

James Smithson
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