Genezen
gene therapy
ProcessEngineerII
Neural analysis suggests this role is
optimal for Mid candidates.
“Process Engineer II at Genezen. Skills: operational support, process development, GMP viral vectors, cell transduction, equipment performance evaluation, troubleshooting, procedure development, process and equipment monitoring, validation / qualification, leadership of small projects, single use manufacturing systems, pharmaceutical / biopharmaceutical equipment commissioning, pharmaceutical / biopharmaceutical equipment validation, pharmaceutical / biopharmaceutical equipment performance monito”
What You'll Achieve.
meeting the challenges of working at a fast-growing company; Every employee contributes to the success of the company; accelerating our partners' programs
Industry & Context.
collaborative problem solvers; Works on problems where analysis of data requires evaluation of numerous factors; Demonstrates good judgement in selecting methods and techniques for obtaining solutions; Provides technical support and analysis for the resolution of deviations, investigations, and process issues
carry a cellular phone and be on call to support manufacturing operations, Physical Demands: Regularly sit for long periods of time, Physical Demands: Frequently required to stand and use reach with hands and arms, Physical Demands: Occasionally required to climb or and stoop, kneel, crouch, or crawl, Physical Demands: Frequently lift and/or move up to 10 pounds, Physical Demands: Rarely lift and/or move up to 40 pounds, Physical Demands: Frequently utilize close vision and the ability to adjust focus
What They're Looking For.
Must Have
BS in Chemical or Mechanical Engineering, 3-5 years of relevant working experience in a comparable position, Must be able to communicate effectively in writing and orally across the organization and at multiple levels, Positive attitude, service oriented, and willingness / ability to perform maintenance on all equipment, systems, and facilities, Must be capable of multi-tasking and performing assignments that have loosely defined objectives which require investigation of numerous variables, Incumbent will be required to carry a cellular phone and be on call to support manufacturing operations, Experience with pharmaceutical / biopharmaceutical equipment commissioning, validation, and performance monitoring
Nice to Have
Experience in cell culture, protein purification, or process control systems is desirable
What You'll Do.
Provides operational support to development
and commercial operations groups including MFG
Supports specification
and implementation of single use manufacturing systems
Works on problems where analysis of data requires evaluation of numerous factors
Demonstrates good judgement in selecting methods and techniques for obtaining solutions
Supports projects to modify/improve equipment
facilities and/or process controls with little supervisory oversight
Provides technical support and analysis for the resolution of deviations
Develops department procedures and specifications
Other duties as assigned
How You'll Work.
Team & Collaboration
collaborative problem solvers; operational support to development, clinical, and commercial operations groups including MFG, FAC, QC, SC, and PD; communicate effectively in writing and orally across the organization and at multiple levels
Communication Scope
communicate effectively in writing and orally across the organization and at multiple levels; talking; hearing; using telephone and e-mail
Process & Methodology
leadership of small projects, Supports projects to modify/improve equipment, facilities and/or process controls with little supervisory oversight
Full Job Description
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. The Process Engineer II plays a key role in supporting Genezen’s gene therapy clinical/commercial manufacturing facility and will provide operational support to all development, clinical, and commercial operations groups including MFG, FAC, QC, SC, and PD. The incumbent will provide a variety of support services including equipment performance evaluation, troubleshooting, procedure development, process and equipment monitoring, validation / qualification, and leadership of small projects. JOB RESPONSIBILITIES: Provides operational support to development, clinical, and commercial operations groups including MFG, FAC, QC, SC, and PD Supports specification, design, testing, and implementation of single use manufacturing systems Works on problems where analysis of data requires evaluation of numerous factors. Demonstrates good judgement in selecting methods and techniques for obtaining solutions Supports projects to modify/improve equipment, facilities and/or process controls with little supervisory oversight Provides technical support and analysis for the resolution of deviations, investigations, and process issues Develops department procedures and specifications Other dutie
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