Job Description

Job Description

Job Description

Sokol GxP Services is seeking an experienced Cleaning Validation Engineer to join our team supporting an oral solid dosage manufacturing project within a Contract Manufacturing Organization (CMO) in the Philadelphia area.

This role is ideal for professionals with a solid foundation in cleaning validation who can work independently, interface directly with clients, and contribute to continuous improvement initiatives in a multi-product GMP environment .

• Lead the development and execution of cleaning validation protocols and reports for oral solid dosage equipment (e.g., blenders, tablet presses, granulators, fluid bed dryers).
• Design and optimize cleaning procedures based on product characteristics, cleaning agent compatibility, and equipment design.
• Perform risk assessments to identify worst-case scenarios and establish scientifically justified residue limits.
• Collaborate with QA, Manufacturing, Engineering, and client technical teams to support cleaning validation activities and tech transfers.
• Conduct and oversee swab and rinse sampling, and coordinate analytical testing.
• Investigate cleaning-related deviations and implement effective CAPAs.
• Support development of SOPs and Cleaning Validation best practices.

Requirements

• Bachelors degree in Chemical Engineering, Pharmaceutical Sciences, Microbiology, or related field.
• 1015 years of experience in cleaning validation, with at least 2 years in oral solid dosage manufacturing within a CMO or GMP setting.
• Familiarity with Validation Documentation Platforms.
• Strong understanding of cGMP, ICH guidelines, and cleaning validation regulatory expectations.
• Proficiency in analytical techniques and residue limit calculations.
• Excellent documentation, communication, and project management skill

• Experience with high-potency APIs and containment strategies.
• Familiarity with automated cleaning systems (CIP/SIP) and cleaning agent qualification.

Benefits

• Competitive pay structure with contract or full-time options
• Health, dental, and vision insurance (for eligible full-time employees)
• 401(k) plan with company match (for eligible full-time employees)
• Paid time off and company holidays
• Per diem and paid lodging for travel assignments
• Flexible work arrangements depending on project scope
• Continuous professional development and training opportunities through Sokol GxP Academy
• Supportive team culture and access to senior validation and CQV experts

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