MBR Analyst

Job Description:

Position Overview: As a Senior MES PASX MBR Modeler you will play a critical role in the design implementation and maintenance of our MBR using Werum PASX V2/V3. You will ensure compliance with industry standards and regulations while optimizing production processes.

Key Responsibilities:

DevelopmentModificationUpgradeEnhancement of MBRs and GMBRs on PASV2V3

Validation and UAT of MBRsGMRESP

Werum PASX Implementation: Design configuration and implementation of Werum PASX 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 PASX 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 PASX systems.

Continuous Improvement: Identify opportunities for process optimization and efficiency improvements within the automation systems and propose solutions.


Qualifications:


Minimum of 58 years of experience in the pharmaceutical industry with a focus on MBR Development on Werum PASX systems.

Bachelors 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 PASX and other pharmaceutical automation systems.

Project management experience with the ability to lead crossfunctional teams.

Excellent problemsolving skills and the ability to work effectively in a teamoriented environment.

Strong communication and documentation skills.

Ability to adapt to changing priorities and manage multiple tasks simultaneously.