Senior MES Engineer I - Remote

Overview

The Sr. MES Engineer I is responsible for the development and delivery of MES master batch records and master data required for system implementation in the Novato facilities. They support the MES (PAS-X) in the areas of user requirements, user configuration & master batch record design, application lifecycle management, system use documentation and ongoing continuous improvement efforts.

In Short

• Work with the PAS-X MES project implementation team to ensure delivery of system recipes and master data.
• Provide On-Call Hypercare Support following the launch of PAS-X.
• Participate in development and maintenance of the MES recipes GMP approval lifecycle documentation.
• Create and maintain MES recipes and master data throughout the lifecycle.
• Support MES training of SMEs and Users.
• Liaise with key business stakeholders to understand business requirements.
• Establish best practices for MES system governance and maintenance.
• Support new process transfers and equipment process changes.
• Provide support for MES system/recipes in coordination with other departments.
• Other duties as assigned.

Requirements

• Minimum of 10 years experience in automation or equivalent type of process controls.
• Minimum 10 years experience in Bio-Pharmaceutical or equivalent type of life science industry.
• Minimum of 5 years experience with Korber PAS-X MES Suite.
• Experience with system implementation and SDLC requirements.
• Understanding of GxPs, FDA and International requirements for computer validation.
• Proficiency with MS Office applications.
• Good verbal and written communication skills.
• Good organizational skills.
• Must have good interpersonal skills.

Benefits

• Flexible/hybrid work location.
• Standard weekday shifts.
• Opportunity to work in a leading biotechnology company.
• Engagement in innovative science and drug discovery.