Cleaning Validation Engineer – Pharma Compliance Expert

Clark & Enersen

Glendale (CA)

On-site

USD 90,000 - 130,000

Full time

4 days ago
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Job summary

ELIQUENT Life Sciences in Glendale, CA is seeking a Cleaning Validation Engineer to design, execute, and maintain cleaning validation protocols that verify effective removal of contaminants and ensure regulatory compliance.

You will collaborate with QA, production, and engineering to develop validation strategies, perform risk assessments, conduct sampling and data analysis, and maintain audit-ready documentation in line with FDA, EMA and ICH guidelines.

Qualifications

  • Bachelor’s degree in Pharmaceutical or Chemical Engineering or related discipline.
  • Experience in cleaning validation within pharmaceutical manufacturing.
  • Strong knowledge of SIP systems and GMP guidelines.
  • Familiarity with FDA/EMA/ICH cleaning validation guidelines.
  • Proficiency in developing validation protocols and technical reports.

Responsibilities

  • Develop, review, and execute cleaning validation protocols and reports per cGMP and regulatory guidelines.
  • Perform risk assessments and establish acceptance criteria for cleaning processes.
  • Collaborate with manufacturing and quality teams to optimize cleaning parameters.
  • Conduct sampling, analytical testing, and data analysis to verify cleaning effectiveness.
  • Maintain audit-ready documentation and ensure regulatory compliance.
  • Investigate deviations or non-conformances related to cleaning validation.
  • Stay current with industry trends and emerging technologies to improve practices.

Skills

SIP systems
Pharmaceutical manufacturing
Validation protocols
Data analysis
Regulatory compliance

Education

Bachelor’s degree in Pharmaceutical Engineering
Bachelor’s degree in Chemical Engineering

Tools

HPLC
TOC
ATP bioluminescence

Job description

ELIQUENT Life Sciences in Glendale, CA is seeking a Cleaning Validation Engineer to design, execute, and maintain cleaning validation protocols that verify effective removal of contaminants and ensure regulatory compliance.

You will collaborate with QA, production, and engineering to develop validation strategies, perform risk assessments, conduct sampling and data analysis, and maintain audit-ready documentation in line with FDA, EMA and ICH guidelines.

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