Manufacturing Systems Engineer

NEUROTECH U S A

Cumberland, RI 02864, USA

Published: 6/14/2022

Manufacturing

Full Time

Job Description

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI and Needham, MA, within Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary drug delivery platform for treatment of a variety of retinal disorders. Our drug delivery platform - Encapsulated Cell Technology (ECT) platform is designed to deliver genetically modified therapeutics to slow the progression of chronic retinal diseases. Our most advanced program is delivering a neurotrophic factor to treat the orphan disease Macular Telangiectasia Type 2 (MacTel) For over two decades, we have pioneered the development of our proprietary Encapsulated Cell Therapy (ECT) platform, designed to address chronic retinal diseases. Our lead program focuses on Macular Telangiectasia Type 2 (MacTel), a rare retinal disorder, leveraging ECT's innovative approach to provide sustained, targeted treatment directly to the eye.

We are seeking an experienced and motivated Manufacturing Systems Engineer who thrives in an innovative and fast-paced small company environment and efficiently communicates and collaborates across functional areas. The successful candidate will play a key role in leading cutting-edge projects and shaping the future of automation technology while ensuring that GMP manufacturing equipment is kept up to date with calibrations, certifications, and validations. In this pivotal role, you'll leverage your extensive experience in automation frameworks, system integration, and process optimization to drive efficiency and excellence across our operations. You’ll collaborate with cross-functional teams, including the validation team and facilities, to design and implement sophisticated automated solutions, focusing on our Automated Manufacturing Encapsulated Cell Technology process.

Essential Functions and Duties

The Manufacturing Systems Engineer is responsible for applying advanced analytical and problem-solving methodologies, including mathematical modeling, simulations, and control theories, to design, develop, and optimize state-of-the-art complex mechanical systems. You must be experienced in mechanical engineering design principles of capital equipment and modeling such systems using statics, dynamics, kinematics, and vibration analyses in different phases of the product life cycle. You must be highly proficient with current development tools, software, practices, and processes:

Applies technical expertise to complex tasks with in-depth knowledge of related work areas.
Employs in-depth knowledge of cross-functional and related technical areas, applying knowledge to other areas.
Works on complex issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
Acts as a Subject Matter Expert (SME) where skill sets make it appropriate.
Utilize mechanical engineering design principles of capital equipment and mechanisms combined with the application of static, dynamic, and kinematic analyses.
Design and develop mechanical subsystems, including concept generation, CAD design, analyses, documentation, verification, and Design for Manufacturing & Assembly, and Design for Reliability for current and new products.
Perform finite element analysis of components and assemblies, 3D tolerance analysis, and different types of modeling using Simulink or MATLAB programming.
Participate in hands-on activities including preventative maintenance, validation execution, engineering tests and characterizations.
Post-process the corresponding test results using mechanical engineering principles and statistical theories.
Ownership of manufacturing validated and future systems, ensuring compliance with GMP requirements, to support the implementation and execution of validation lifecycle management associated with each system, from standalone temperature chambers to semi-automated and automated manufacturing systems, electronic batch records, and CGMP software programs.

Education and Experience

BS or MS in Biomedical Engineering, Biotechnology, Chemical Engineering, Mechanical Engineering, or a related field. [CG1] [RG2]
3+ years of experience in a biotech or pharmaceutical manufacturing environment, with a focus on equipment validation and compliance.
Demonstrated experience in bioprocess development and optimization, including upstream processing.
Familiarity with regulatory requirements and guidelines related to biotech, including FDA, EMA, and ICH standards.
Experience with process scale-up and technology transfer from R&D to manufacturing.
Proficient in data analysis and statistical process control methodologies.
Experience [CG3] troubleshooting process equipment using root cause analysis
Knowledge of automation in biotech processes, including PLC programming and control systems.
Experience with project management principles and tools.

Knowledge, Skills, and Abilities

Familiar with FDA/EMEA/USP/EP regulated CGMP requirements.
Strong understanding of bioprocessing principles, including upstream processing.
Familiarity with quality control and quality assurance practices within a biotech setting.
Experience with validation practices, including process validation and cleaning validation.
Multi-axis robot programming and integration (6-axis) a plus.
Programming skills and experience using analytical and simulation tools, including C++, MATLAB, SolidWorks CAD modeling, SolidWorks SIM, SolidWorks Motion Analysis, Beckhoff TwinCAT.
Precision Mechanical Assembly.
LabVIEW, experience with sensors and DAQ systems.
Experience with motion control and applied control theories are highly desired.
Experience with defining system requirements, writing User Requirement Specifications (URS), Functional Specifications (FS), Design Specifications (DS), and Commissioning Specifications (CS) validation documents