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Sr. Process Engineer
Charles River Laboratories International Inc (CRL)
Memphis, TN, US, 38118
IMPORTANT: In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process. Please make sure work history and education are added correctly.
Job Summary
We are seeking a Sr. Process Engineer for our Cell Therapy Manufacturing Facility located Memphis, TN.
The Sr. Process Engineer will serve as a senior engineer and provide equipment and facility technical support for incoming technology transfers of client manufacturing processes for advanced cell therapies. This role will participate in the transfer process and ensuring that the knowledge transfer to the manufacturing and supporting groups is efficient and effective. Additionally, this role will lead process equipment improvements, assessments, investigations, and implementations as governed by the site procedures and/or client requirements.
The following are responsibilities related to the Sr. Process Engineer:
- Work as part of a cross-functional transfer team to ensure maximum and high-quality output of deliverables for clients.
- Leads facility fit assessments during technology transfer of new client manufacturing processes.
- Leads equipment related risk assessments with other cross functional groups and leadership.
- Experienced and knowledgeable of how key product quality attributes can be impacted by equipment functionality.
- Leads in assessing client manufacturing requirements against internal capabilities to identify any equipment or facility gaps.
- Technical review documentation supporting tech transfer and production and provide technical support.
- Provides SME support for equipment related investigations and support to facilities to address any adverse equipment events.
- Monitor and analyze transferred process performance (Manufacturing) and troubleshoot technical difficulties as requested by management.
- Ensures tasks are performed in a manner consistent with safety standards and within cGMP guidelines.
- Knowledgeable in drawing editing software and leads modification of process area drawings.
- Leads improvement projects expanding process knowledge, controls for technology transfer consistency, and continuous improvement.
- Travel may be required for training or process transfer activities.
- Autonomy in this role will be high.
- Performs other duties as assigned.
Job Qualifications
The following are minimum qualifications related to the Sr. Process Engineer position:
- BS in engineering or life sciences with a minimum of 5 year or equivalent applicable experience.
- MS / PhD in engineering or life sciences with a minimum of 3 year or equivalent applicable experience.
- Highly experienced equipment and processing knowledge of cell culture and/or cGMP processing.
- Must be detail oriented and have excellent organizational skills.
- Must possess effective written and oral communication skills.
- Must display a high degree of professionalism and confidentiality.
- Must demonstrate initiative to remain apprised of relevant industry and regulatory trends.
- Experienced in equipment commissioning, FAT, SAT, and qualification.
- Experience with design software (AutoCAD, BlueBeam, or SolidWorks), a plus.
- Experience with statistical software (MATLAB or JMP), a plus.
IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV.
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 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 OpportunityCharles 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 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.
Job posted: 2023-02-12
