Pipette and Certification Technician
Wayne, PA, US, 19087
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
Perform the calibration of laboratory pipettes and oversee pipette maintenance to ensure production standards are continuously met. Perform certifications of test containment equipment and associated components i.e. biological safety cabinets, isolators, fume hoods, and ISO classified cleanrooms in a cGMP environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Follow pre-set schedule to calibrate laboratory pipettes to ensure calibration standards and guidelines are met.
• Enter data in validated computer systems and provide documentation in compliance with cGMPs
• Coordinate upcoming calibrations with Operational departments and communicate required maintenance. Maintain pipette log in compliance with cGMPs
• Provide various services regarding certification, smoke studies, maintenance, and repair of biological safety cabinets, and perform a variety of tests to verify the protective effectiveness of cabinets in accordance with applicable standards.
• Knowledge of relevant industry standards (FDA, ISO 8655, ISO 14644-1, USP 800, USP 797 and IEST-RP-CC-006)
• Verify biological safety cabinet HEPA filter integrity and measure air velocity, differential pressures, airborne particulate, visualization of airflow and directional airflow in the working environment and inside the cabinets.
• Ability to perform ambient, florescent, ultra-violet light tests and noise level tests.
• Make recommendations for preventative maintenance, replacement parts, and repairs.
• Follow Standard Operating Procedures for calibrations, certification methods, and all areas of responsibility. Responsible for documentation as required by company policy, cGMP, and FDA
• Complete all work orders associated with the Preventative Maintenance (PM) program according to schedule and document maintenance in appropriate locations
• Match all work orders to calibration/ certification sheets and verify work orders for accuracy.
• Work in a cleanroom environment following standard operating procedures and training guidelines
• Maintain up to date records of required cGMP internal trainings and knowledgeable of any external changes to NSF and ISO requirements regarding Biological Safety Cabinets and Clean Rooms
• Perform off-hours alarm response when designated.
• Perform all other related duties as assigned.
Job Qualifications
• Education: Trade school graduate or equivalent
• Experience: Two to four years of experience in laboratory, mechanical, electrical, or electronic field
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
• Knowledge of safety cabinet functionality
• In depth knowledge of hood and cabinet testing standards and test instrumentation is required
• Experience performing various field tests to verify air flows, HEPA filter integrity, containment of contaminated cabinet air, and test for other cabinet operational features.
• Ability to identify faulty safety cabinet conditions and make appropriate repairs.
• Knowledge of NSF and ISO requirements
• Certification/Licensure: None
• Other: Able to organize workload effectively, accomplish tasks in a timely fashion and work independently. Strong computer skills for data entry
Compensation Data
The pay range for this position is $26.83 per hour. 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 supported the development of 86% of the drugs approved by the FDA in 2021.
Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.
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 [email protected]. 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: Philadelphia
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