Sr. Cleaning Validation Engineer

Corden Pharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical, and biotech companies manufacture medicines with the ultimate goal of improving people's lives.

Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms:
Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

Our People Vision

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

SUMMARY

The Sr. Cleaning Validation Engineer role supports all aspects of product changeover equipment cleaning, ranging from cleaning development to cleaning execution on the plant floor; and ensures cleaning processes are effective, efficient, and meet industry guidance and best practices. This position continually improves the cleaning processes through scale-up of cleaning development, upgrading equipment, troubleshooting of cleaning-related issues, and identifying and implementing opportunities to reduce cleaning times.

Monitors and improves cleaning key performance indicators, such as cleaning time and solvent usage.

Experience with process equipment and Clean-in-Place (CIP) Skid design, commissioning, and qualification strongly preferred. Experience working in classified clean rooms strongly preferred. Experience in Cleaning Verification/ Validation in chemical API manufacturing preferred.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Authors and approves product changeover cleaning documentation including cleaning strategy documents, cleaning verification protocols, and cleaning validation protocols
• Performs and documents equipment cleanability assessment, equipment cleaning quality risk assessments, and recommends equipment modification for designing equipment for cleanability. Completes change controls and equipment qualification documentation related to equipment design for cleanability
• Mentors cross functional groups, both internal and external, on CAPEX design consideration and performance of equipment cleanability assessments for new and existing equipment
• Creates and maintains cleaning-related SOPs to be in compliance with quality risk assessments, corporate directives, and latest industry standards; and harmonizes applicable cleaning SOPs between Corden Pharma Colorado API sites
• Leads and participates in Operational Excellence projects to implement SMED initiatives and visual management of changeover cleaning
• Collects key performance indicator metrics on number of product changeover cleaning, changeover cleaning times, and cleaning delays (including cause of delay and mitigation solutions)
• Investigates and resolves cleaning deviations and trends through completion of investigation reports and implementation of related CAPAs
• Participates in cleaning development technical meetings and provides input on operational requirements for critical cleaning parameters (solvent/concentration, contact time, temperature, etc.) to ensure product changeover cleaning can be efficiently and effectively executed in the plants
• Works with cross functional departments in Production, Development, and QA to proactively plan and manage generation of cleaning documentation (including cleaning development reports, cleaning analytical methods, cleaning strategy documents, cleaning protocols, and other non-routine cleaning-related documents, etc.) to ensure these are completed in a timely fashion to meet the production schedule
• Works with Production Management and Process Implementation Specialists to ensure cleaning briefings are developed and training is delivered prior to the changeover cleaning
• Troubleshoots equipment related challenges during cleaning operations. Tracks cleaning debrief action items and owns changes to equipment cleaning procedures
• Represents Corden Pharma Colorado on Corden Corporate Cleaning Team and implements best practices from other sites
• Supports client and regulatory audits as a Subject Matter Expert in cleaning verification and validation

LEADERSHIP & BUDGET RESPONSIBILITIES

There are no direct reports for this position, but it is responsible for providing leadership for continuous improvement of equipment cleanability and cleaning processes. Periodic assignments of significant responsibility levels for large projects. This position will work closely with Production Managers and Implementation Specialists to ensure cleaning is completed efficiently and Right First Time.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of their activities in the workplace. Each…