Cleaning Validation Analyst
Zoetis
6 months ago
On-site
Lincoln, NE
Operations
Benefits Include:
- $500 Sign on Bonus
- 4 weeks accrued paid vacation and 13 paid holidays.
- 401(k) match with company profit sharing.
- Tuition reimbursement and Student Loan repayment program.
- Great Health, personal, and family benefits starting day 1.
Position Summary
The Cleaning Validation Analyst supports cleaning validation programs across pharmaceutical and biological operations at the Lincoln manufacturing site. You will collect samples from manufacturing equipment and perform analytical chemistry testing using HPLC, AAS, UV/Vis, and TOC. You will also author task reports and protocols and contribute to documentation activities including database management, SOP updates, and investigation reports.
Hours: 1st Shift. Overtime, weekends, and holidays may be required.
Position Responsibilities
- Obtain samples from manufacturing equipment as outlined in Cleaning Validation protocols.
- Prepare and analyze samples using HPLC, AA, UV/Vis, and TOC according to Standard Test Procedures.
- Document laboratory results and perform data review using Good Laboratory Practices (GLP).
- Maintain cGMP compliance with departmental SOPs, Zoetis Quality Standards, and regulatory guidelines (21CFR, EU, and others).
- Assist with development of cleaning validation protocols and write validation task reports.
- Support scheduling and administrative duties including database maintenance, SOP updates, and investigation reports.
- Assist with analytical method validation.
Education and Experience
- Minimum Qualifications: 2 or 4-year degree/certificate in a science-based field with analytical laboratory experience.
- Preferred Qualifications: Bachelor’s degree in chemistry or related field with knowledge or direct experience using HPLC, AA, TOC, and UV/Vis instrumentation.
Technical Skills and Competencies Required
Minimum Technical Skills/Competencies:
- Physical ability to collect samples from manufacturing equipment.
- Ability to perform analytical chemistry assays following Standard Test Procedures.
- Familiarity with cGMPs and cGLPs.
- Verbal and written communication skills (fluent in English).
- Knowledge of Microsoft Word and Excel.
- Organizational skills, attention to detail, and collaboration.
Preferred Technical Skills/Competencies:
- Prior analytical laboratory experience with proficiency using HPLC, AA, TOC, and UV/Vis.
- Experience with Waters Empower Chromatography Data System.
- Knowledge of FDA/EU guidelines as they relate to cleaning validation.
- Technical writing skills.
- Ability to establish timelines to meet key milestones with minimal supervision.
- Ability to work effectively in a team-based environment.
Physical Position Requirements
- Mobility for sample collection, including reaching overhead, squatting, and occasional use of a step ladder.
- Ability to lift materials up to 15 lbs.
- Occasional off-shift and weekend hours.
- $500 Sign on Bonus
- 4 weeks accrued paid vacation and 13 paid holidays.
- 401(k) match with company profit sharing.
- Tuition reimbursement and Student Loan repayment program.
- Great Health, personal, and family benefits starting day 1.
Position Summary
The Cleaning Validation Analyst supports cleaning validation programs across pharmaceutical and biological operations at the Lincoln manufacturing site. You will collect samples from manufacturing equipment and perform analytical chemistry testing using HPLC, AAS, UV/Vis, and TOC. You will also author task reports and protocols and contribute to documentation activities including database management, SOP updates, and investigation reports.
Hours: 1st Shift. Overtime, weekends, and holidays may be required.
Position Responsibilities
- Obtain samples from manufacturing equipment as outlined in Cleaning Validation protocols.
- Prepare and analyze samples using HPLC, AA, UV/Vis, and TOC according to Standard Test Procedures.
- Document laboratory results and perform data review using Good Laboratory Practices (GLP).
- Maintain cGMP compliance with departmental SOPs, Zoetis Quality Standards, and regulatory guidelines (21CFR, EU, and others).
- Assist with development of cleaning validation protocols and write validation task reports.
- Support scheduling and administrative duties including database maintenance, SOP updates, and investigation reports.
- Assist with analytical method validation.
Education and Experience
- Minimum Qualifications: 2 or 4-year degree/certificate in a science-based field with analytical laboratory experience.
- Preferred Qualifications: Bachelor’s degree in chemistry or related field with knowledge or direct experience using HPLC, AA, TOC, and UV/Vis instrumentation.
Technical Skills and Competencies Required
Minimum Technical Skills/Competencies:
- Physical ability to collect samples from manufacturing equipment.
- Ability to perform analytical chemistry assays following Standard Test Procedures.
- Familiarity with cGMPs and cGLPs.
- Verbal and written communication skills (fluent in English).
- Knowledge of Microsoft Word and Excel.
- Organizational skills, attention to detail, and collaboration.
Preferred Technical Skills/Competencies:
- Prior analytical laboratory experience with proficiency using HPLC, AA, TOC, and UV/Vis.
- Experience with Waters Empower Chromatography Data System.
- Knowledge of FDA/EU guidelines as they relate to cleaning validation.
- Technical writing skills.
- Ability to establish timelines to meet key milestones with minimal supervision.
- Ability to work effectively in a team-based environment.
Physical Position Requirements
- Mobility for sample collection, including reaching overhead, squatting, and occasional use of a step ladder.
- Ability to lift materials up to 15 lbs.
- Occasional off-shift and weekend hours.