eTeam
Manufacturing & Process Engineer_L3
eTeam - Raritan, New Jersey, us, 08869
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Overview
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Overview
Role Name: MES Engineer
Location: New York, NY / Raritan, NJ
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 MBR's and GMBR's on PAS-X V3 (V 3.1.8 or higher) • Validation and UAT of MBR's\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 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 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. • Bachelor's degree in engineering, Computer Science, or a related field. Masters 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.
Location: New York, NY / Raritan, NJ
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 MBR's and GMBR's on PAS-X V3 (V 3.1.8 or higher) • Validation and UAT of MBR's\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 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 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. • Bachelor's degree in engineering, Computer Science, or a related field. Masters 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.