Cleaning Validation Engineer

Job Description

Job Description

Job Title: Cleaning Validation Engineer

Location: Crystal Lake

Hire Type: Direct Hire

Compensation: $95,000–$105,000/year

Benefits: PTO, paid holidays, medical/dental/vision, retirement plan

Position Summary:

We are seeking a Cleaning Validation Engineer to support cleaning validation activities within a GMP-regulated pharmaceutical manufacturing environment. This role is responsible for developing, executing, and maintaining cleaning validation programs to ensure manufacturing equipment and processes meet regulatory and quality standards.

The ideal candidate will have experience with cleaning validation protocols, technical documentation, GMP compliance, and cross-functional collaboration within pharmaceutical manufacturing.

Key Responsibilities:

• Lead cleaning validation activities for new equipment, process changes, and continuous improvement projects
• Develop and execute cleaning validation protocols, sampling plans, and final reports
• Evaluate validation data to ensure cleaning effectiveness, repeatability, and compliance
• Support change controls, deviations, investigations, and CAPAs related to cleaning validation
• Partner with Manufacturing, Engineering, QA, QC, and Regulatory teams on validation initiatives
• Assist with residue limits, recovery studies, and acceptance criteria development
• Maintain validation documentation, SOPs, and quality standards
• Support internal and external regulatory inspections as a cleaning validation SME
• Review and approve controlled documents within area of expertise
• Support training and mentoring of validation personnel as needed

Qualifications:

• Bachelor’s degree in Engineering, Chemistry, Biology, or related scientific discipline preferred
• 3+ years of validation experience in pharmaceutical manufacturing
• Direct cleaning validation experience strongly preferred
• Strong understanding of cGMPs, validation principles, and regulated manufacturing environments
• Experience writing and executing validation protocols and reports
• Excellent technical writing, analytical, and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment
• Strong communication and cross-functional collaboration skills

Qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or genetic information.