Systems Engineer MES

Req ID #:  161097
Location: 

Memphis, TN, US, 38118

For 70 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 an experienced Systems Engineer - MES for our Cell-and Gene Therapy Digital Team site located in Memphis, TN.

The Systems Engineer - MES is responsible for the development and implementation of our manufacturing execution system and digital manufacturing solutions. The System Engineer – MES will transform the product vision, design, and requirements into compliant solutions and will directly influence how users interact with the system. The Systems Engineer - MES is well versed with next generation manufacturing operational management technologies and invests energy to continuously develop their technical skills. This individual will also be responsible for driving adoption of the enterprise toolsets and act as technical consultant to adjacent departments. A love for clean interfaces and automation, and a passion for a great user experiences goes without saying.
 
Essential Duties and Responsibilities:


•    Configures applications and GxP automated software systems according to the design, business, and user requirements.
•    Provides feedback and suggest tradeoffs when required.
•    Deciphers existing companies’ software systems and integrates applications with applicable data sources.
•    Write both unit and integration tests and develop automation tools for daily tasks.
•    Troubleshoot and resolve technical problems with software tools and systems when they arise.
•    Develop and refine development workflows that facilitates rapid software releases.
•    Work closely with vendors to design, develop, and release software tools and applications.
•    Develop high quality, well documented, and efficient code.
•    Challenge ideas and opinions to avoid pitfalls and inefficient solutions.
•    Lead, author, support, and perform activities in the following areas: technical design documentation (System Design Specification, System Requirements Specification), Standard Operating Procedures (SOPs), user training, user acceptance testing (UAT), software validation, quality event management – nonconformances, deviations, investigations, and change controls.
•    Perform all other related duties as assigned.

Job Qualifications

 

The following are minimum requirements related to the Systems Engineer - MES position:
 
•    Associates degree (A.A./A.S.) or equivalent in Computer Science, Software Engineering, Computer Engineering, or related discipline; technical bootcamps or course certificates are a plus. 
•    Ability to work independently with minimal supervision.
•    Strong understanding of Agile methodologies.
•    Highly motivated, collaborative, and able to prioritize effectively in a fast-paced, multi-tasking environment.
•    Strong communicator in software, automation, and software system architectures.
•    Experience working on a software development team and launching software products.
•    Experience as a developer using Linux, Python, PostgreSQL, REST, SQL, JavaScript, HTML, and CSS.
•    Understand APIs and proficient in writing tests for them.
•    Demonstrated ability to solve problems independently and become the subject matter expert on issues as required.
•    Great debugging skills, not afraid to jump into code if needed to debug production issues.
•    Experience as a Developer on a cross-functional agile team preferred.

 

Preferred Qualifications: 


•    Knowledge and application of Good Automated Manufacturing Practice (GAMP) framework for risk-based approach to computer system validation.
•    Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals.
•    Experience in developing Manufacturing Execution Systems (MES) i.e. L7|ESP, Werum, Emerson, Siemens or similar products. 
•    Experience with deploying RESTful APIs.

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. 


Vaccine Mandate
Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees. 


Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

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 18,000 employees within 100 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 >80% of the drugs approved by the FDA for the past 3 years.


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, 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.

 

For more information, please visit www.criver.com.
  


Nearest Major Market: Memphis

Job Segment: Manufacturing Engineer, Systems Engineer, Pharmaceutical, Testing, Test Engineer, Engineering, Science, Technology