Cleaning Process & Validation Engineer

Job Title : Cleaning Process & Validation Engineer

Location : Holly Springs, NC

Experience : 4+ years

Type : 12+ Months Contract

About the Role

We are seeking multiple Cleaning Process & Validation Engineers to support a large site build-out in Holly Springs. This role will begin with a strong focus on documentation and protocol development (first 3 4 months), then shift into field-based cleaning validation once engineering runs begin. You will be involved in protocol execution, sample collection, swabbing, and validation activities directly on the manufacturing floor.

Key Responsibilities

Conduct PQs (Performance Qualifications) for parts washers and cleaning equipment

Define cleaning parameters and execute sampling activities

Support and optimize CIP (Clean-in-Place) procedures and systems

Develop and execute cleaning validation protocols, reports, and risk assessments

Perform cleaning validation studies including sampling, testing, and data analysis

Investigate and resolve deviations and discrepancies related to cleaning validation

Collaborate with Quality Assurance, Manufacturing, Engineering, and vendor teams to integrate validation activities into project timelines

Maintain accurate, compliant documentation of all cleaning validation activities

Must-Have Qualifications

Bachelor's Degree in Engineering or related field

4+ years of hands-on cleaning validation experience in a regulated pharmaceutical environment

Strong knowledge of cGMP documentation and the validation lifecycle

Proven experience writing validation protocols, reports, risk assessments, and handling deviations

Proficiency with Kneat (highly preferred)

Experience in greenfield, brownfield, or new facility build-outs (desirable)

Preferred / Plus Skills

Cleaning validation experience with both small parts and large-scale equipment such as bioreactors