CP
Sr. Cleaning Validation Engineer
Accepting applicationsCorden Pharma - A Full-Service CDMO · Boulder, CO
Full-Time Mid_senior ATEMentorSICaiarm
Posted
9h ago
Category
Test
Experience
Mid_senior
Country
United States
CordenPharma 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 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, 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.
This post will expire July 6, 2026
Show more Show less
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 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, 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.
This post will expire July 6, 2026
Show more Show less