Sr. Cleaning Validation EngineerRegular Full-Time ProfessionalBoulder, CO, USSalary Range: $110,000.00 To $131,000.00 AnnuallySUMMARYThe 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.ESSENTIALDUTIESAND RESPONSIBILITIESAuthors and approves product changeover cleaning documentation including cleaning strategy documents, cleaning verification protocols, and cleaning validation protocolsPerforms 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 cleanabilityMentors cross functional groups, both internal and external, on CAPEX design consideration and performance of equipment cleanability assessments for new and existing equipmentCreates 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 sitesLeads and participates in Operational Excellence projects to implement SMED initiatives and visual management of changeover cleaningCollects 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 CAPAsParticipates 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 plantsWorks 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 scheduleWorks with Production Management and Process Implementation Specialists to ensure cleaning briefings are developed and training is delivered prior to the changeover cleaningTroubleshoots equipment related challenges during cleaning operations. Tracks cleaning debrief action items and owns changes to equipment cleaning proceduresRepresents Corden Pharma Colorado on Corden Corporate Cleaning Team and implements best practices from other sitesSupports client and regulatory audits as a Subject Matter Expert in cleaning verification and validationLEADERSHIP & BUDGETRESPONSIBILITIESThere 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 RESPONSIBILITIESEvery individual is personally responsible for the safety and environmental aspects of their activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.QUALITY RESPONSIBILITIESCorden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC's Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.QUALIFICATIONSTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.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.Certificates, licenses, registrations: None.CORE COMPETENCIESKnowledge of chemistry, chemical processing equipment, chemical processing, cleaning, verification/validation, and high potent and cGMP operationsLeadership and delegation skillsDemonstrated mechanical aptitudeDemonstrated training and facilitation skillsExcellent written and verbal communication skillsProficient in Microsoft Word, Excel, and Visio professionalSALARYActual pay will be based on your skills and experience.BENEFITS401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of serviceCritical Illness InsuranceDisability InsuranceEmployee Assistance ProgramFlexible Spending AccountHealth Insurance PPO/HSAHospital Indemnity PlanID Theft ProtectionLife InsuranceTuition ReimbursementWellness ProgramVision InsuranceEQUAL OPPORTUNITY EMPLOYERCorden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.#J-18808-Ljbffr