Cleaning Validation Engineer - Oral Solid Dosage (CMO, Mid-Level)
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.
Responsibilities:
- 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.
- Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Microbiology, or related field.
- 10–15 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
Preferred Skills:
- Experience with high-potency APIs and containment strategies.
- Familiarity with automated cleaning systems (CIP/SIP) and cleaning agent qualification.
- 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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