Senior CIP Development & Cleaning Validation Consultant

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

JobOverview

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.

How to Apply

Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

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