Cleaning Validation Engineers

VTI Life Sciences

$90K — $120K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree or higher in Engineering, Chemistry, Pharmaceutical Sciences, or a related scientific field
  • 4+ years of experience in the Biotechnology or Pharmaceutical industries
  • Strong knowledge of cleaning validation principles, including MACO calculations and PDE-based limits
  • Proficient in technical writing and protocol/report development
  • Skilled in analyzing complex data and troubleshooting validation issues
  • Effective communication and cross-functional collaboration skills
  • Familiarity with validation lifecycle management and quality management systems (e.g., TrackWise, Kneat, Veeva)

Responsibilities

  • Develop and execute cleaning validation protocols and reports per regulatory guidelines
  • Establish acceptance criteria for residues and cleaning limits
  • Perform and document visual inspections and residue sampling
  • Coordinate validation activities with Manufacturing and QA
  • Analyze laboratory data for residuals testing and interpret results
  • Investigate cleaning failures and implement corrective actions
  • Partner with Engineering and Operations to optimize cleaning processes

Benefits

  • Opportunity to work onsite at a prominent Biotechnology facility
  • Gain experience in a regulatory-compliant environment
  • Exposure to cross-functional collaboration with Engineering and Operations
  • Build technical skills in cleaning validation and quality assurance
  • Potential for contract extension beyond initial duration
Full Job Description
We are currently looking for multiple Cleaning Validation Engineers to work onsite at our client's facility in Glendale, CA. Job Title: Cleaning Validation Engineers Industry: Biotechnology Level of Experience: 4+ years Location: Glendale, CA (On-Site) Duration: Through the end of the year + (Initial Contract) Responsibilities - Develop and execute cleaning validation protocols, reports, and risk assessments in accordance with cGMP, FDA, EMA, and other regulatory guidelines. - Establish scientifically justified acceptance criteria for residues and cleaning limits. - Perform and document visual inspection assessments and residue sampling (swab and rinse methods). - Coordinate validation activities with Manufacturing and QA to ensure proper execution during production campaigns. - Analyze laboratory data for residuals testing and interpret results to determine cleaning process effectiveness. - Investigate cleaning failures, deviations, and nonconformities; implement corrective and preventive actions (CAPAs). - Partner with Engineering and Operations to optimize cleaning processes and support new equipment commissioning. - Support change control activities related to equipment modifications, new product introductions, or updated cleaning procedures. - Write and maintain SOPs related to cleaning validation and verification programs. - Ensure documentation meets global regulatory expectations, internal quality standards, and audit readiness. Requirements - Bachelor's degree or higher in engineering, Chemistry, Pharmaceutical Sciences, or a related scientific field. - 4+ years of experience in the Biotechnology or Pharmaceutical industries - Strong knowledge and experience implementing cleaning validation principles (MACO calculations, PDE-based limits, swab/rinse recovery studies). - Strong technical writing and protocol/report development skills. - Ability to analyze complex data and troubleshoot validation issues. - Effective communication and cross-functional collaboration skills. - Proficiency with validation lifecycle management systems and quality management systems (TrackWise, Kneat, Veeva, etc., a plus).

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