Cleaning Validation Chemist

Actalent; Lincoln (NE); On-site; USD 34,000 - 49,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

PTO / Vacation

Job summary

Actalent is seeking a Chemistry Lab Validation Specialist in Lincoln, NE, to support cleaning validation and analytical testing in a regulated lab. You will perform swab, rinse, and equipment sampling and execute HPLC, UV/Vis, TOC, and AAS analyses to verify effective cleaning and residue removal.

The role emphasizes GLP/good cGMP documentation, method validation, and cross-functional collaboration with QA, Manufacturing, Engineering, and Validation teams.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Biology, or a related 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 (HPLC, TOC, UV/Vis, AA/AAS).
• Strong knowledge of cGMP/GLP principles and FDA/pharma quality standards.

Responsibilities

• Collect swab, rinse, and equipment samples from manufacturing areas following validated cleaning protocols.
• Perform analytical testing using HPLC, UV/Vis, TOC, AA/AAS and other techniques to assess cleanliness.
• Analyze data to evaluate cleaning effectiveness and support validation conclusions.
• Prepare, review, and maintain GLP/cGMP compliant documentation and reports.
• Assist in developing and reporting cleaning validation studies and method transfers.
• Support method validation and transfer activities with experimental work and results.
• Ensure compliance with FDA, EU and internal quality standards and SOPs.
• Investigate OOS or atypical results and support corrective actions.
• Update SOPs, databases, and validation documents as needed.
• Collaborate with QA, Manufacturing, Engineering and Validation teams to meet schedules.
• Support audits with accurate, well-organized documentation.

Skills

Analytical chemistry

HPLC

TOC

UV/Vis

AAS

GLP/GMP

Data analysis

Technical writing

Team collaboration

Independent work

Education

Bachelor's degree in Chemistry or related field

Tools

HPLC

UV/Vis

TOC

AA/AAS

Laboratory instrumentation

Job description

Actalent is seeking a Chemistry Lab Validation Specialist in Lincoln, NE, to support cleaning validation and analytical testing in a regulated lab. You will perform swab, rinse, and equipment sampling and execute HPLC, UV/Vis, TOC, and AAS analyses to verify effective cleaning and residue removal.

The role emphasizes GLP/good cGMP documentation, method validation, and cross-functional collaboration with QA, Manufacturing, Engineering, and Validation teams.