MBR Engineer

2 weeks ago

Raritan, United States Ztek Consulting Full time

Job Title: MBR Engineer

Location: 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. 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

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