Cleaning Validation Engineer

Staftonic LLC; Illinois; On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Cleaning Validation Engineer to develop and maintain cleaning validation strategies. This role involves ensuring compliance with cGMP regulations and optimizing cleaning processes for safety and efficacy. Candidates should have a relevant degree and at least three years of experience in the field.

Qualifications

• Minimum of 3 years’ hands-on experience in cleaning validation.
• In-depth knowledge of cGMP standards and regulatory guidelines.
• Experience with cleaning processes for liquid product manufacturing.

Responsibilities

• Author, review, and execute cleaning validation protocols.
• Evaluate and improve cleaning processes for equipment.
• Collaborate with cross-functional teams to support validation initiatives.

Skills

Analytical thinking

Documentation

Communication

Education

Bachelor’s degree in Chemistry, Chemical Engineering, Life Sciences

Job description

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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.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Pharmaceutical Manufacturing and Biotechnology Research