| MBR Engineer at Raritan, New Jersey, USA |
| Email: [email protected] |
| From: Santhoshi, HAN IT Staffing [email protected] Reply to: [email protected] Role : MBR Engineer - Hybrid Location: Raritan, NJ Client : Capgemini Job Description : Position Overview: As a Senior MES PAS-X MBR Modeler you will play a critical role in the design, implementation, and maintenance of our MBR using Werum PAS-X V2/V3. You will ensure compliance with industry standards and regulations while optimizing production processes. Key Responsibilities: Development\\Modification\\Upgrade\\Enhancement of MBRs and GMBRs on PAS-X V3 (V 3.1.8 or higher) Validation and UAT of MBRs\\GMR\\ESP Werum PAS-X Implementation: Design, configuration, and implementation of Werum PAS-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 PAS-X systems to ensure maximum uptime and operational efficiency. Validation: Manage the validation and qualification processes for developed MBRs, 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 PAS-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 PAS-X systems. Bachelors 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 PAS-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. Keywords: information technology New Jersey MBR Engineer [email protected] |
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| Sat May 18 00:48:00 UTC 2024 |