Senior CIP Development & Cleaning Validation Consultant

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

About The Company Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

About The Company Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.
Position: Senior CIP Development & Cleaning Validation Consultant
Location: New York
Duration : Long Term
Job Overview We are seeking an experienced Senior CIP Development & Cleaning Validation Consultant with 5+ years of experience in Cleaning Validation, CIP development, and biologics manufacturing.
Key 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.

Required 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.

Experience With Monoclonal Antibody (mAb) Manufacturing Is Preferred.

• Knowledge of upstream processes such as cell culture and harvest.
• Experience with downstream processes such as chromatography and TFF.
• Experience with CIP systems and stainless‑steel process equipment.
• Familiarity with LabWare, Veeva, or similar systems.
• Experience with startup, commissioning, qualification, or facility implementation.
• Strong troubleshooting and problem‑solving skills.
• Good communication and teamwork skills.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.