What are the responsibilities and job description for the Cleaning Validation Engineer position at Intellectt Inc?
Job Title: Cleaning Validation Engineer
Location: Holly Springs, North Carolina
Duration:6-12 months
What You’ll Do
- Develop and execute cleaning validation protocols (IQ/OQ/PQ).
- Conduct visual inspections, swab and rinse sampling, and coordinate laboratory analysis.
- Analyze cleaning validation data and generate detailed technical reports.
- Support equipment cleaning assessments and risk analyses (e.g., MACO calculations, risk-based approaches).
- Collaborate with QA, Manufacturing, Engineering, and Regulatory teams.
- Lead investigations and CAPAs related to cleaning deviations or failures.
- Stay updated on regulatory guidelines (FDA, EMA, WHO, PIC/S) related to cleaning validation.
- Participate in audits and inspections, providing technical support for cleaning validation topics.
What We’re Looking For
- Bachelor’s degree in Chemical Engineering, Pharmaceutical Sciences, Microbiology, or related field.
- 2 years of experience in cleaning validation within a GMP-regulated facility (pharmaceutical, biotech, or medical device).
- Strong understanding of cleaning validation principles, regulatory expectations, and industry best practices.
- Experience with analytical methods used in cleaning validation (e.g., HPLC, TOC).
- Familiarity with risk assessment tools (FMEA, HACCP, etc.).
- Excellent documentation and technical writing skills.
- Strong organizational and communication skills.
