Chemistry Lab Technician

Job Title:

Chemistry Lab Validation Specialist

Job Description This role focuses on supporting cleaning validation and analytical testing within a regulated chemistry laboratory. The position involves performing swab, rinse, and equipment sampling from manufacturing areas, executing analytical methods, and ensuring that cleaning procedures effectively remove product residues and contaminants. The Chemistry Lab Validation Specialist contributes to method validation and transfer activities, maintains accurate documentation in compliance with GLP and cGMP standards, and collaborates closely with cross-functional teams to support manufacturing and validation projects.

Responsibilities

• Collect swab, rinse, and equipment samples from manufacturing areas in accordance with approved cleaning validation protocols.
• Perform analytical testing using HPLC, UV/Vis, TOC, Atomic Absorption (AA/AAS), and other laboratory techniques to assess cleanliness and verify removal of product residues and contaminants.
• Compile, analyze, and interpret laboratory data to evaluate the effectiveness of cleaning procedures and support validation conclusions.
• Prepare, review, and maintain laboratory documentation, including test records, logs, and reports, in strict compliance with GLP and cGMP requirements.
• Assist in the development, execution, and reporting of cleaning validation studies, ensuring protocols and reports are scientifically sound and compliant with regulatory expectations.
• Support analytical method validation and method transfer activities by performing experiments, documenting results, and contributing to technical reports.
• Maintain compliance with FDA, EU, and internal quality standards, standard operating procedures (SOPs), and applicable regulatory requirements.
• Investigate out-of-specification (OOS) or atypical laboratory results, perform root cause analysis, and support the implementation of corrective actions.
• Update SOPs, databases, validation protocols, and technical reports related to cleaning and analytical validation activities.
• Collaborate with Quality Assurance, Manufacturing, Engineering, and Validation teams to support production schedules, resolve issues, and advance validation projects.
• Participate in internal and external audits and provide accurate, well-organized documentation to support regulatory inspections.
• Ensure laboratory equipment is calibrated, maintained, and operating properly, and promptly report or address any issues impacting data integrity or test performance.

Essential Skills

• Bachelors degree in Chemistry, Biochemistry, Biology, or a related scientific field.
• Minimum of 2+ years of experience in chemistry testing or a similar analytical laboratory role.
• Hands-on experience with analytical chemistry techniques and instrumentation, including HPLC, TOC, UV/Vis, and AA/AAS.
• Strong understanding of cGMP and GLP principles and their application in a laboratory setting.
• Knowledge of FDA and pharmaceutical manufacturing requirements and quality standards.
• Proficiency in laboratory data analysis, including evaluation of test results and trending.
• Strong technical writing skills for preparing protocols, reports, and laboratory documentation.
• High attention to detail and accuracy in documentation and data recording.
• Ability to work independently to manage day-to-day testing activities and meet deadlines.
• Ability to work effectively in a team environment and collaborate with cross-functional partners.

Additional

Skills & Qualifications

• Experience in wet chemistry techniques and general laboratory operations.
• Experience in analytical chemistry, including method development or optimization, is beneficial.
• Familiarity with updating and maintaining SOPs, technical reports, and validation documentation.
• Com…