Overview
Quality Engineer Jobs in Wilmington, DE at Katalyst Healthcares & Life Sciences
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.
CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.
Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.
SUMMARY
This role will support all Quality Assurance activities related to cleaning verification and validation for CordenPharma Colorado and CordenPharma Boulder in accordance with the appropriate cGMP requirements for an API Contract Manufacturing and Development Organization (CDMO). Assures consistent quality of products by developing and enforcing cGMP Systems as related to cleaning activities. The individual will assure that processes, documentation, and systems conform to internal quality standards.
This position will be responsible for identifying potential challenges with respect to compliance, production, or testing activities related to cleanability and potential carryover risk. This role will provide Quality oversight for equipment, standard operating procedures, change controls, deviations, CAPA and technical documents, and other tasks as assigned.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned.
Approves and provides quality oversight on cleaning strategy documents, cleaning verification and validation protocols, cleaning auxiliary documents (as applicable) and change controls, deviation, and CAPAs
Works directly with Manufacturing and other departments responsible for cleaning activities to resolve deviations and other compliance issues in a timely manner
Provides Quality Assurance oversight on equipment upgrades and qualification projects, as related to improvements in cleanability and to reduce carryover risk
Participates and provides quality oversight in equipment cleanability assessment and equipment cleaning risk assessments as necessary
Participates and provides quality oversight on equipment cleaning related operational excellence projects
Trains and mentors other Quality Department staff on equipment cleaning requirements
LEADERSHIP & BUDGET RESPONSIBILITIES
None.
SAFETY & ENVIRONMENTAL RESPONSIBILITIES
Every individual is personally responsible for the safety and environmental aspects of his or her 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.
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
High School Diploma or General Education Degree (GED) and 3 years related experience in the pharmaceutical industry; or equivalent combination of education and experience. An understanding of Chemical Concepts and cGMP Manufacturing preferred.
LANGUAGE SKILLS
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, regulatory agencies, and/or boards of directors.
MATHEMATICAL SKILLS
Competence in scientific mathematical skills and statistics, including metric analysis, trending, and reporting.
REASONING ABILITY
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
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; and stoop, kneel, crouch, or crawl. 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, 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 wet and/or humid conditions, moving mechanical parts, and outside weather conditions. 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 chemical processing equipment, chemical processing, cleaning, validation, and high potent and cGMP operations
Familiarity with Manufacturing and Regulatory Requirements for cleaning validation
Good customer service skills, as well as effective interpersonal and conflict resolution skill
Strong math skills
Strong reading comprehension
Demonstrated mechanical aptitude
Demonstrated training and facilitation skills
Excellent written and verbal communication skills
Effective writing and editing skills; attention to detail is a must
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 Maternity/Paternity Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance
This post will expire on June 28, 2025
Show more
Title: Quality Engineer
Company: Katalyst Healthcares & Life Sciences
Location: Wilmington, DE
