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.