Cleaning Validation Engineer Job at Intellectt Inc, Lansdale, PA

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  • Intellectt Inc
  • Lansdale, PA

Job Description

Role: Cleaning Validation Engineer

Location: Lansdale/West Point, PA

Duration: Long Term

Job Summary

Seeking a professional to lead Cleaning Validation and CQV (Commissioning, Qualification, and Validation) activities in a regulated manufacturing environment. This role ensures compliance with cGMP and global regulatory standards through cross-functional collaboration.

Key Responsibilities

  • Lead CQV for CIP, SIP, automated washers, and manual cleaning systems .
  • Develop and execute IQ, OQ, PQ protocols .
  • Author and review validation protocols, risk assessments, and reports.
  • Conduct cleaning validation studies, including residue sampling, swab/wipe testing, and worst-case simulations .
  • Investigate deviations, perform root cause analysis , and implement CAPAs .
  • Collaborate with Engineering, Quality, Production, and EHS to resolve technical issues.
  • Ensure compliance with FDA, EMA , and internal QMS .
  • Support audits/inspections and provide training on cleaning validation.
  • Drive continuous improvement in cleaning processes.

Qualifications

  • Bachelor’s degree in Engineering, Chemistry, Biochemistry , or related field.
  • 5+ years ’ experience in cleaning validation or CQV in pharma/biotech .
  • Strong knowledge of cGMP , validation protocols, and sampling techniques.
  • Skilled in technical writing , QMS tools (e.g., SAP, TrackWise), and data integrity.

Job Tags

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