Sr. Validation Engineer (Cleaning Validation)
Sterling Engineering, Inc.
- Waukegan, IL
- 5 days ago
- $60–$75 Per Hour
Highlights
Experience with MACO, HBEL/PDE, worst-case assessments, swab/rinse sampling, recovery studies, and routine monitoring is highly desirable. I am looking for someone with extensive hands-on pharmaceutical cleaning-validation experience who has served as an SME or technical lead.
Numbers & Facts
| Location | Waukegan, IL |
| Industry | Staffing/Employment Agencies |
| Salary | $60–$75 Per Hour |
| Company Size | 500 to 999 employees |
| Year Founded | 1969 |
| Website | http://www.sterling-engineering.com |
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.
About Company
Sterling Engineering has been a trusted partner for engineering, project management, and staffing solutions for over five decades. We provide exceptional engineering/technical recruitment and engineering project services to clients nationwide:
- Engineering & Technical Recruitment - With our focus on engineering, technical, and IT, Sterling has the in-depth knowledge, industry expertise, and robust employee pipeline it takes to rapidly find talent for even the most difficult to fill positions. Sterling’s extensive recruitment methodology allows us to engage the most talented employees in the marketplace. We offer exciting work and career-building opportunities for our candidates, along with expert support at every step of the process.
- Engineering Project Services – Our experienced, multi-disciplined team of project managers, engineers, and designers, led by licensed Professional Engineers (PE), provide project management, engineering, design, and Commissioning, Qualification, and Validation (CQV) to manufacturing, OEM, and R&D customers. We work on complex, highly technical projects across a number of industry sectors, and our ability to scale and seamlessly integrate at multiple levels of your organization is what differentiates us.
Sterling offers a unique combination of engineering solutions and Best of Staffing level service to help our clients and talent achieve their goals.
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