Automation Engineer

Automation Engineer Req ID #:  175253 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 Automation Engineer for our Biologics site located in Memphis, TN.

The Automation Engineer has responsibility to execute Lifecycle management and Digital Modernization related projects for supporting Cell Therapy operations. The Automation Engineer works closely with laboratory and manufacturing scientists to successfully develop and convert manually performed methodologies to automated platforms

The following are responsibilities related to the Automation Engineer:

•    Engage with scientists across multiple departments to design and implement automation solutions, with the goal to increase efficiencies, capacity, turnaround times, and reduce opportunities for human error.

•    Collaborate with operations staff/scientists to convert manual assays to automated platforms.

•    Install, test, and validate/qualify new automation systems, and adapt existing automation systems to ensure they meet scientific needs, user functionality, and regulatory requirements.

•    Support technical integration of platform services with application development teams across the global technology organization and product software teams.

•    Be a hands-on guide to support end users when faced with technical issues and provide comprehensive training and documentation to enable the end user to use the automation platform autonomously.

•    Assist in the preparation of validation deliverables for computerized systems, including:Validation Plans, Requirements Specification, Configuration Specifications, Risk Assessments, Test Scripts, Traceability Matrices, Validation Summary Reports.

•    Manage equipment software settings including protocols/recipes/assay settings. 

•    Coordinate and schedule automation system vendors with respect to the execution of Installation, Operation, and Performance Qualification (IQ/OQ/PQ) protocols, and subsequent re-qualification protocols if applicable for new and in-use equipment to ensure compliance with site procedures, Master Validation Plan (MVP), and regulatory requirements.

•    Provide system training to appropriate laboratory staff.

•    Participate in the development of corrective actions as needed for deficiencies that may be uncovered/observed during validation efforts in regard to equipment, processes, test methods, facilities, computer software/systems, SOPs, and other related issues in order to assure compliance with applicable regulatory requirements/guidelines, procedures, and policies.

•    Participate in the development of CAPA’s and assess the effectiveness of the corrective action.

•    Schedule validation project team meetings to assure project milestone schedules are maintained and deliverables satisfy requirements.

•    Assist as needed during client and regulatory audits and help to resolve or mitigate audit findings related to automated systems.

•    Participate in risk assessment activities to evaluate new and existing threats or non-compliance and prepare for remediation.

•    Perform all other related duties as assigned.

  Job Qualifications  

The following are the minimum qualifications related to the Automation Engineer position:

•    Bachelor of Science degree in science or engineering field or equivalent experience in automation or laboratory or related field.

•    Minimum of 2 years laboratory automation and computerized system validation related experience in a pharmaceutical, biotechnology and/or biomedical industry.

•    Working knowledge of lab equipment/instrumentation, test method, process, and facility validation in a regulated environment.

•    Must have excellent oral and written communication skills.

•    Strong documentation development and technical writing skills

•    Must have in-depth knowledge of accepted industry practices and the regulatory requirements that govern Computer System Validation in the pharmaceutical industry. 21 CFR Parts 210, 211, 820, 11, EU Annex-11, and applicable ICH and FDA guidance’s.

•    Leadership ability, project management, and facilitation skills required.

•    Must have good interpersonal, organizational, and analytical skills.

Preferred Qualifications:

•    Bachelor's degree (B.A./B.S.) or equivalent in IT discipline, Chemical Engineering, or related technical field.

•    Knowledge of data center operation and IT infrastructure.

•    Knowledge of network connectivity and network services.

•    Knowledge of REST APIs, SQL, and object orientated programming.

•    Knowledge and experience with MES, LIMS, and database systems. 

•    Knowledge and experience with QC Lab and Manufacturing Instrument software such as: Nucleoview, FACSuite, DataPro, Endoscan-V.

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.  Our main priority is the wellbeing, health, and safety of our people. We require 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

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