Process Engineer I

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 Process Engineer I will provide process support and technical expertise to clinical and commerical client manufacturing processes for advanced cell therapies. This role will usher processes and programs through their lifetimes within the Memphis Cell Therapy manufacturing facility. This role will be instrumental in gathering and performing real time in process review of process parameters (i.e. cell counts, viability, flow, etc.). There will be a large emphasis on aseptic process simulation design and reports as well as facilitating process impact assessments.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

* Work as part of a cross-functional team to ensure maximum and high quality output of deliverables for clients

* Completes tasks to facilitate routine manufacturing operations and/or complex internal projects with support from PE's and management

* Assists in trending and reports on process data

* Contributes and drafts APS protocols with input from Sr. Eng

* Supports the evaluation of impact assessments for QMS documentation

* Starting to build knowledge of how key product quality attributes can be impacted by process and equipment functionality

* Participates in assessing client manufacturing requirements against internal capabilities to identify any equipment or facility gaps

* Assists in the generation of PPQ protocols and execution

* Assists on investigations and major deviations

* Assists in generating documents that will facilitate the annual process validation reviews.

* Assists in generating the documentation supporting APS design and final reports.

* Will provide support for process and equipment related investigations and support to the operations team to address any adverse 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

* Travel may be required for training or process transfer activities

* Autonomy in this role will be minimal

* Perform all other related duties as assigned

**Job Qualifications**

* BS/MS in engineering or life sciences

* Minimum 0 years or equivalent applicable experience

* Candidate has knowledge on 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

* Experience with design software (AutoCAD, BlueBeam, or SolidWorks), a plus.

* Experience with statistical software (MATLAB or JMP), a plus.

* Experience in equipment commissioning, FAT, SAT, and qualification, a plus.

**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 .... 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.

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