MBR Engineer

MBR Engineer
Location: Raritan, NJ
Hybrid Working Model

Position Overview: As a Senior MES Client-X MBR Modeler you will play a critical role in the design, implementation, and maintenance of our MBR using Werum Client-X V2/V3. You will ensure compliance with industry standards and regulations while optimizing production processes.
Key Responsibilities:
•DevelopmentModificationUpgradeEnhancement of MBR's and GMBR's on Client-X V3 (V 3.1.8 or higher)
•Validation and UAT of MBR'sGMRESP
•Werum Client-X Implementation: Design, configuration, and implementation of Werum Client-X systems to ensure seamless integration with existing pharmaceutical manufacturing processes.
•Project Leadership: Take charge of MBR Development, from inception to completion, ensuring adherence to project timelines and budget constraints.
•Compliance: Ensure all automation processes comply with industry regulations, including GMP (Good Manufacturing Practices) and FDA guidelines.
•System Maintenance: Oversee the maintenance, troubleshooting, and optimization of Werum Client-X systems to ensure maximum uptime and operational efficiency.
•Validation: Manage the validation and qualification processes for developed MBR's, ensuring they meet user requirement and specification.
•Documentation: Maintain comprehensive documentation of automation processes, including SOPs (Standard Operating Procedures) and change control documentation.
•Training: Provide training and support to colleagues and team members to ensure their proficiency in Werum Client-X systems.
•Continuous Improvement: Identify opportunities for process optimization and efficiency improvements within the automation systems and propose solutions.
Qualifications:
•Minimum of 5-7 years of experience in the pharmaceutical industry with a focus on MBR Development on Werum Client-X systems.
•Bachelor's degree in engineering, Computer Science, or a related field. Master's degree is a plus.
•Strong knowledge of GMP, FDA regulations, and industry best practices.
•Proficiency in Werum Client-X and other pharmaceutical automation systems.
•Project management experience, with the ability to lead cross-functional teams.
•Excellent problem-solving skills and the ability to work effectively in a team-oriented environment.
•Strong communication and documentation skills.
•Ability to adapt to changing priorities and manage multiple tasks simultaneously.