Cleaning Validation Engineers

VTI Life Sciences•Gleandale, CA

2d•Onsite

About The Position

VTI Life Sciences (VTI) is seeking forward-thinking and ambitious engineers looking to accelerate their careers in the pharmaceutical, biotechnology, and medical device industries. We offer an opportunity to help support our teams of industry subject matter experts and thought leaders while consulting with some of the biggest companies in the Life Sciences industry. We are currently looking for multiple Cleaning Validation Engineers to work onsite at our client's facility in Glendale, CA.

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.

Nice To Haves

Proficiency with validation lifecycle management systems and quality management systems (TrackWise, Kneat, Veeva, etc., a plus).

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.