Sr. Validation Engineer (Cleaning Validation)
$60 - $75 per hourSterling Engineering Inc.
Job Description
Job Description
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.
Experience with MACO, HBEL/PDE, worst-case assessments, swab/rinse sampling, recovery studies, and routine monitoring is highly desirable.
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.
Vacancy posted 2 days ago
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