Lead Cleaning Validation Engineer (Pharma SME)

Sterling Engineering; Waukegan (IL); On-site; USD 83,000 - 110,000; Full time

Job summary

Sterling Engineering seeks a Subject Matter Expert with Cleaning Validation for U.S. pharmaceutical manufacturing.

You will bring 10+ years of hands-on experience and serve as SME or technical lead on cleaning-validation projects, ensuring GMP compliance and lifecycle management. Responsibilities include executing Cleaning Validation Quality Plan deliverables, reviewing protocols and data, identifying deviations, and guiding site resources.

Qualifications

• 10+ years of hands-on cleaning-validation experience in pharmaceutical or biopharmaceutical manufacturing.
• Previous experience as 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 review data critically and identify gaps in science, technology, or compliance.
• Experience investigating cleaning-validation deviations or failures and recommending 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.

Responsibilities

• 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

Skills

Cleaning validation expertise

GMP compliance

Technical leadership

Data analysis

Tools

MACO

HBEL/PDE

swab sampling

recovery studies

protocols & reports review

Job description

Sterling Engineering seeks a Subject Matter Expert with Cleaning Validation for U.S. pharmaceutical manufacturing.

You will bring 10+ years of hands-on experience and serve as SME or technical lead on cleaning-validation projects, ensuring GMP compliance and lifecycle management. Responsibilities include executing Cleaning Validation Quality Plan deliverables, reviewing protocols and data, identifying deviations, and guiding site resources.