Sr. Cleaning Validation Engineer

Corden Pharma Colorado• Boulder, CO, US, CO

8h•$110,000 - $131,000•Onsite

About The Position

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 cleanrooms strongly preferred. Experience in Cleaning Verification/ Validation in chemical API manufacturing preferred.

Requirements

Bachelor of Science in a Science or Engineering related major and five years related experience in a GMP API Manufacturing Environment; or equivalent combination of education and experience.
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Ability to write routine reports and correspondence.
Ability to speak effectively to groups of employees or visitors.
Ability to apply basic concepts of arithmetic, algebra and geometry.
Ability to calculate figures and amounts such as raw material charges, unit conversions, proportions, percentages, area, circumference, and volume.
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
Ability to deal with problems involving several abstract concepts in unique situations.
Knowledge of chemistry, chemical processing equipment, chemical processing, cleaning, verification/validation, and high potent and cGMP operations
Leadership and delegation skills
Strong math skills
Strong reading comprehension
Demonstrated mechanical aptitude
Demonstrated training and facilitation skills
Excellent written and verbal communication skills
Proficient in Microsoft Word, Excel, and Visio professional

Nice To Haves

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

Responsibilities

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

Benefits

401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance