Cleaning Validation Engineer

QCS Staffing; North Carolina; On-site; USD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical organization is seeking a Cleaning Validation Engineer for a 6-month contract in North Carolina. The position involves participating in CQV conversations, documenting cleaning strategies, and ensuring compliance with regulatory standards. This is a crucial role contributing to the establishment of a new manufacturing facility on the East Coast.

Qualifications

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

Responsibilities

• Document a strategy for executing cleaning validation at the site.
• Write and review cleaning and sanitization procedures.
• Serve as SME for presenting cleaning validation to regulatory bodies.

Skills

Cleaning Validation

Quality Assurance

Project Management

Regulatory Compliance

Job description

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

Essential Duties and Responsibilities for this role include, but are not limited to:

• Participate in CV conversations for CQV including all necessary functions such as operations, QA, QC, process support, supply chain, etc., and gain alignment as needed.
• Liaise with the operational readiness team and third-party contractors to build connections and define interactions related to cycle development and hold times.
• Document a strategy for how CV will be executed at the site.
• Write and review cleaning and sanitization procedures and maintain the Cleaning Validation Master Plan.
• Work with project managers to develop tracking tools for CV activities.
• Serve as SME for presenting cleaning validation to Regulatory bodies (FDA), internal, and external auditors.
• Identify all necessary SOPs and deadlines, and collaborate with responsible functions to ensure delivery.
• Partner with QC teams to determine appropriate CV methods and sampling strategies.

This role offers an exciting opportunity to contribute to a new manufacturing facility on the East Coast of the US, with a global pharmaceutical organization experiencing growth and investment.

Requirements:

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

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

Additional Details:

• Seniority level: Mid-Senior level
• Employment type: Contract
• Job function: Quality Assurance and Engineering
• Industries: Pharmaceutical Manufacturing and Biotechnology Research

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