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Cleaning Validation Engineer

Quanta Consultancy Services Ltd

North Carolina

On-site

USD 80,000 - 100,000

Full time

26 days ago

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Job summary

A global pharmaceutical manufacturing organization seeks a Cleaning Validation Engineer for a 6-month contract in North Carolina. This role involves collaborating with various teams to ensure successful cleaning validation processes and compliance with regulatory requirements, making it an exciting opportunity in a growing facility.

Qualifications

  • Extensive experience on large-scale projects.
  • Significant experience in a Cleaning Validation role.
  • Experience with greenfield projects is a plus.

Responsibilities

  • Participate in CV discussions and ensure alignment among teams.
  • Develop and document a strategy for executing CV at the site.
  • Write and review cleaning and sanitization procedures.

Skills

Cleaning Validation
Project Coordination
Regulatory Compliance

Job description

Cleaning Validation Engineer - US, North Carolina (6 Months Contract)

Our client, a global pharmaceutical manufacturing organization, is seeking a talented Cleaning Validation Engineer to join their expanding team. With ongoing growth and significant investments across their portfolio and capital projects, this is an exciting opportunity to contribute to their new manufacturing facility on the East Coast of the United States.

Essential Duties and Responsibilities:
  • Participate in CV discussions for CQV, including operations, QA, QC, process support, supply chain, and other relevant functions, ensuring alignment.
  • Coordinate with the operational readiness team and third-party contractors to establish interactions related to cycle development and hold times.
  • Develop and document a strategy for executing CV at the site.
  • Write and review cleaning and sanitization procedures; maintain the Cleaning Validation Master Plan.
  • Collaborate with project managers to develop tracking tools and provide visibility into CV activities.
  • Serve as SME for presenting cleaning validation to Regulatory bodies (FDA), internal, and external auditors.
  • Identify required SOPs and deadlines, working with responsible teams to ensure timely delivery.
  • Partner with QC teams to determine appropriate CV methods and sampling strategies.
Requirements:
  • Extensive experience on large-scale projects.
  • Significant experience in a Cleaning Validation role or similar.
  • Experience with greenfield projects is a plus.

If you are interested, please apply now for immediate consideration and further information. #LI-NR1

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