Validation Engineer I
Rockville, MD, US, 20850
For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.
Job Summary
The Validation Engineer I is responsible for supporting the execution of equipment, utilities, and facility validation activities in compliance with GMP regulations and company procedures. This role involves hands-on protocol development, execution, data analysis, and documentation under the guidance of senior validation personnel.
Key Responsibilities and Duties:
- Preparation, execution, and documentation of validation protocols (IQ/OQ/PQ) for manufacturing equipment, analytical equipment, utilities, and facility systems.
- Coordinate and schedule system vendors with respect to the execution of Installation, Operation, and Performance Qualification (IQ/OQ/PQ) protocols, and subsequent Re-qualification (RQ) protocols, if applicable, for new and in-use equipment to ensure compliance with site procedures, Validation Master Plan, and regulatory requirements.
- Participate in change control and deviation investigations related to validated systems.
- Collaborated cross-functionally with Quality Assurance, Engineering, Manufacturing, and IT.
- Organize an efficient method to ensure all requirements of assigned validation deliverables are completed and that validation efforts are executed in a timely manner.
- Maintain accurate and complete validation documentation in compliance with data integrity principles (ALCOA++)
- Participate in the development of corrective actions, as needed, for deficiencies that may be uncovered/observed during validation efforts regarding equipment, processes, test methods, facilities, computer software/systems, SOPs, and other related issues to ensure compliance with applicable regulatory requirements/guidelines, procedures, and policies.
- Participate in the development of CAPA’s and assess the effectiveness of corrective action.
- Participate in validation project team meetings to ensure project milestone schedules are maintained and deliverables satisfy requirements.
- Assist, as needed, during client and regulatory audits and help to resolve or mitigate audit findings related to system qualification/validation.
- Validation contractor oversight, as needed.
- Perform all other related duties, as assigned.
Job Qualifications
- Bachelor’s degree or equivalent in a scientific, Engineering, IT discipline, or related field.
- Experience: 0-3 years of experience in validation, quality, or engineering roles within a regulated (GMP) environment. Internship or co-op experience in pharmaceutical, biotech, or medical device industries is a plus.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Must have excellent oral and written communication skills. Strong documentation development and technical writing skills are critical to this position.
- Understanding of validation principles and regulatory requirements, (e.g., FDA 21 CFR Part 11, EU Annex 15) is a plus.
- Leadership ability, project management, and facilitation skills required. Must be proficient with Microsoft Office software (Word, Excel, PowerPoint). Must have good interpersonal, organizational, and analytical skills.
Compensation Data
The pay rate for this role is $67,000 - $78,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.
About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.
With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.
At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.
We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.
Equal Employment Opportunity
Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.
It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.
For more information, please visit www.criver.com.
Nearest Major Market: Washington DC
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