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).