Cleaning Validation Engineer

Staftonic; Town of Texas (WI); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player in pharmaceutical manufacturing is seeking a skilled Cleaning Validation Engineer to join their dynamic team. This role offers the chance to contribute to the launch of a cutting-edge manufacturing facility on the East Coast. As a key player in a rapidly growing organization, you will collaborate with cross-functional teams to develop and execute effective Cleaning Validation strategies. Your expertise will ensure compliance with regulatory standards and support successful site qualifications. If you're ready to make a significant impact in a pivotal role, this opportunity is perfect for you.

Qualifications

• Experience in Cleaning Validation within pharmaceutical manufacturing.
• Strong understanding of regulatory requirements and compliance.

Responsibilities

• Develop and document a comprehensive Cleaning Validation strategy.
• Serve as SME for Cleaning Validation during audits and inspections.

Skills

Cleaning Validation

Regulatory Compliance

Cross-Functional Collaboration

Documentation

Project Management

Education

Bachelor's Degree in Engineering or related field

Relevant Certifications

Tools

Cleaning Validation Master Plan

SOPs

Regulatory Inspection Tools

Job description

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Position: Cleaning Validation Engineer

Location: Texas

Long Term Contract

Our client, a leading global pharmaceutical manufacturing organisation, is seeking a skilled Senior Cleaning Validation Engineer to join their growing team. This role offers a unique opportunity to contribute to the launch of a state-of-the-art manufacturing facility on the East Coast of the United States. As part of a company experiencing significant growth and investment, this position plays a critical role in shaping future operations and regulatory success.

Key Responsibilities:

• Collaborate across cross-functional teams—CQV, Operations, QA, QC, Process Support, Supply Chain, and others—to align on Cleaning Validation (CV) strategy and execution.
• Coordinate with the operational readiness team and external contractors to define operational interactions related to cleaning cycle development and hold times.
• Develop and document a comprehensive Cleaning Validation strategy tailored to the new site.
• Author and review cleaning and sanitization procedures; maintain and update the Cleaning Validation Master Plan.
• Partner with the CV team at a sister site in Denmark to leverage existing SOPs and methodologies, and create a localized implementation plan for the Holly Springs facility.
• Define and align roles and responsibilities across all support teams involved in Cleaning Validation.
• In collaboration with the CV Lead, establish and execute a communication plan to keep stakeholders informed of CV progress and milestones.
• Work with project managers to implement tools for tracking and visibility of CV activities.
• Ensure the CV approach meets all applicable regulatory requirements and supports successful site qualification and future inspections.
• Serve as the Subject Matter Expert (SME) for Cleaning Validation during internal audits and regulatory inspections, including presentations to the FDA.

Seniority level

• Mid-Senior level

Employment type

• Contract

Industries

• Engineering Services, Medical Equipment Manufacturing, and Pharmaceutical Manufacturing

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