Senior CIP & Cleaning Validation Lead – Biologics

Stark Pharma Solutions Inc; Buffalo (NY); On-site; USD 120,000 - 170,000; Full time

Job summary

Stark Pharma Solutions Inc. in New York seeks a Senior CIP Development & Cleaning Validation Consultant with 5+ years in Cleaning Validation, CIP development, and biologics manufacturing. You will work closely with Engineering, Manufacturing, and Quality teams to ensure robust validation strategies and compliant documentation.

The role emphasizes developing, optimizing, and troubleshooting CIP cycles, performing TOC sampling, and adhering to GMP requirements in a biopharma setting.

Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, Life Sciences, or a related field.
• 5+ years of experience in Cleaning Validation, CIP development, or process validation.
• Hands-on experience with TOC swab and rinse sampling.
• Experience with cleanability and degradation studies.
• Experience with CIP cycle development and troubleshooting.
• Strong knowledge of Cleaning Validation and GMP requirements.
• Experience in pharmaceutical or biologics manufacturing.

Responsibilities

• Support cleanability and degradation studies.
• Perform TOC swab and rinse sampling.
• Execute cleaning validation protocols.
• Develop, optimize, and troubleshoot CIP cycles.
• Support CIP skid and process equipment implementation.
• Analyze cleaning process data.
• Troubleshoot cleaning performance issues.
• Support validation protocols and documentation.
• Work with Engineering, Manufacturing, Quality, and Validation teams.
• Follow GMP requirements and site procedures.

Skills

TOC sampling

Cleaning validation

CIP development

GMP knowledge

Biologics manufacturing

Troubleshooting

Education

Bachelor's degree in Engineering, Chemistry, Biology, Life Sciences

Tools

LabWare

Veeva

Job description

Stark Pharma Solutions Inc. in New York seeks a Senior CIP Development & Cleaning Validation Consultant with 5+ years in Cleaning Validation, CIP development, and biologics manufacturing. You will work closely with Engineering, Manufacturing, and Quality teams to ensure robust validation strategies and compliant documentation.

The role emphasizes developing, optimizing, and troubleshooting CIP cycles, performing TOC sampling, and adhering to GMP requirements in a biopharma setting.