Cleaning Validation Engineer

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Job Title: Cleaning Validation Engineer

Long Term Contract

Position Overview:

We are seeking a dedicated and detail-oriented Cleaning Validation Engineer to join our team in North Carolina. The successful candidate will be responsible for developing, executing, and maintaining cleaning validation strategies in compliance with cGMP regulations and global regulatory expectations. This role supports the manufacturing of liquid pharmaceutical products by ensuring equipment cleaning processes are validated and optimized for safety, efficacy, and compliance.

Key Responsibilities:

• Author, review, and execute cleaning validation protocols and reports aligned with cGMP, FDA, EU, and internal quality standards.
• Evaluate and improve cleaning processes for equipment used in the production of liquid formulations.
• Collaborate closely with cross-functional teams including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs to support validation initiatives.
• Conduct risk assessments and gap analyses; propose and implement corrective and preventive actions to ensure validation readiness.
• Stay current on industry trends, evolving regulatory requirements, and best practices in cleaning validation and process optimization.

Qualifications:

• Bachelor’s degree in Chemistry, Chemical Engineering, Life Sciences, or a related discipline.
• Minimum of 3 years’ hands-on experience in cleaning validation within the pharmaceutical, biotechnology, or similarly regulated industry.
• In-depth knowledge of cGMP standards and regulatory guidelines (FDA, EU).
• Demonstrated experience with cleaning processes for liquid product manufacturing.
• Strong analytical thinking, documentation, and communication skills.

Preferred Qualifications:

• Experience with automated cleaning systems such as CIP (Clean-In-Place) and SIP (Steam-In-Place).
• Familiarity with validation lifecycle management tools and software systems.

Mid-Senior level

Contract

Pharmaceutical Manufacturing and Biotechnology Research