Position: Cleaning Validation SME

Location: Waukegan, IL 60087
Hire Type: Contract
Compensation: $60.00 - $75.00 per hour

Benefits: As a contract employee of Sterling, you are eligible to receive a Full Employee Benefits Package that includes paid time off, paid holidays, 3 medical plans to choose from, dental & vision plans, 401(k), and an Employee Stock Ownership (ESOP) plan.

I am looking for someone with extensive hands-on pharmaceutical cleaning-validation experience who has served as an SME or technical lead.

Job Duties: 

• Execute Cleaning Validation Quality Plan deliverables
• Provide technical leadership and guide site resources
• Review protocols, reports, data, and quality records
• Assess deviations, trends, failures, and compliance gaps
• Support routine monitoring and lifecycle management
• Troubleshoot complex cleaning-validation issues
• Partner with Quality, Manufacturing, Engineering, and Validation

 Qualifications:  

• 10+ years of experience hands-on cleaning-validation experience within pharmaceutical or biopharmaceutical manufacturing.
• Previous experience serving as a Cleaning Validation SME, technical lead, or senior validation engineer.
• Strong understanding of GMP cleaning-validation principles and lifecycle management.
• Experience executing, maintaining, or remediating Cleaning Validation Quality Plans.
• Experience with cleaning-validation protocols, reports, sampling plans, and routine monitoring.
• Ability to critically review data and identify scientific, technical, or compliance gaps.
• Experience investigating cleaning-validation deviations or failures and recommending appropriate actions.
• Strong technical writing, documentation-review, and data-analysis skills.
• Demonstrated ability to guide and mentor validation or quality resources.
• Strong cross-functional communication and stakeholder-management 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.