Sr. Process Engineer
Job Description
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.
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.
