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CQV Temperature Mapping Engineer

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. Life Sciences
37825
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CQV Temperature Mapping Engineer - US, North Carolina - 5 Monts 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.

Essential Duties and Responsibilities for this role include, but are not limited to:
  • 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.
  • Utilise 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
 Requirements:
  • Bachelor’s degree in Engineering, Science, Pharmacy, or related field.
  • Extensive 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 you are interested, please apply now for immediate consideration and further information.

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