Senior CIP Development & Cleaning Validation Consultant

Senior CIP Development & Cleaning Validation Consultant

ONSITE- Syracuse, NY

Position Summary

We are seeking an experienced CIP Development and Cleaning Validation Consultant to support a biologics manufacturing operation through the execution of cleanability studies, degradation studies, and Cleaning-In-Place (CIP) cycle development activities. This individual will work closely with Cleaning Validation, Manufacturing, and Engineering teams to support new CIP systems and process equipment associated with monoclonal antibody (mAb) manufacturing operations.

The ideal candidate will bring strong hands-on experience performing TOC sampling, supporting laboratory-based cleaning studies, executing cleaning validation activities, and troubleshooting CIP cycle performance within GMP-regulated biologics manufacturing environments.

Key Responsibilities

• Support laboratory-based cleanability and degradation studies used to establish and optimize cleaning processes.
• Perform TOC swab and rinse sampling activities to evaluate cleaning effectiveness.
• Execute cleaning validation and cycle development protocols within GMP manufacturing environments.
• Support development, optimization, and troubleshooting of new CIP cycles for process equipment and vessels.
• Partner closely with Cleaning Validation, Engineering, Manufacturing, and Quality stakeholders during equipment startup and cleaning process implementation.
• Analyze cleaning process data and provide technical recommendations to improve cycle effectiveness and operational efficiency.
• Assist in troubleshooting cleaning performance issues encountered during CIP cycle development and execution.
• Participate in protocol execution activities and provide technical review and feedback on validation and investigation documentation.
• Support implementation of new CIP skids, product vessels, and associated cleaning systems.
• Maintain compliance with GMP requirements, site procedures, and industry best practices.

Required Qualifications

• Bachelor's degree in Engineering, Chemistry, Biology, Life Sciences, or a related technical discipline.
• Minimum 5 years of experience supporting Cleaning Validation, CIP development, process validation, or related engineering functions within pharmaceutical or biotechnology manufacturing.
• Demonstrated hands-on experience with TOC swab and rinse sampling techniques.
• Experience executing cleanability studies and degradation studies in a laboratory environment.
• Proven experience supporting on-floor CIP cycle development and troubleshooting activities.
• Strong understanding of Cleaning Validation principles and regulatory expectations within GMP manufacturing environments.
• Experience supporting biologics manufacturing processes.
• Ability to work effectively within a collaborative team environment while contributing independent technical expertise.
• Strong communication and problem-solving skills.

Preferred Qualifications

• Experience supporting monoclonal antibody (mAb) manufacturing facilities.
• Familiarity with upstream manufacturing operations including cell culture and harvest processes.
• Experience supporting downstream purification processes including chromatography and tangential flow filtration (TFF).
• Experience implementing and optimizing CIP systems associated with stainless steel process equipment.
• Exposure to electronic systems such as LabWare, Veeva, or comparable quality and laboratory platforms.
• Previous startup, expansion, commissioning, qualification, or facility-scale implementation experience.

Desired Experience

Candidates should possess practical experience supporting:

• CIP skid implementation and startup activities
• CIP cycle optimization and troubleshooting
• Cleaning validation execution
• Process vessel cleaning strategies
• Biologics manufacturing equipment cleaning
• Cross-functional collaboration with Validation, Engineering, Manufacturing, and Quality teams