Sr. Cleaning Validation Engineer

Sr. Cleaning Validation Engineer

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.

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 employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

Quality Responsibilities

Corden 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.

Qualifications

To 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.

Education and/or Experience

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.

Language Skills

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.

Mathematical Skills

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.

Reasoning Ability

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.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to fumes or airborne particles and low levels of toxic or caustic chemicals, moving mechanical parts, outside weather conditions, and risk of electrical shock. The noise level in the work environment is usually moderate.

Core Competencies

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

• 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

Salary: Actual pay will be based on your skills and experience.

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

Equal Opportunity Employer: Corden 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,