Senior MES Engineer, San Rafael

Job Title: Senior MES Engineer (PAS-X) Biopharmaceutical Manufacturing
Job Type: Full-time
Location: United States (Hybrid 2 days/week onsite in California)
Industry: Pharmaceutical / Biotechnology

About the Role

A leading biotechnology organization is seeking a Senior MES Engineer with deep expertise in Korber PAS-X MES Suite to support the implementation and lifecycle management of MES systems in a regulated biopharmaceutical manufacturing environment. This hybrid position offers a unique opportunity to contribute to the deployment of digital manufacturing technologies in alignment with GMP and global quality standards.

Key Responsibilities

Lead the development, configuration, and maintenance of MES master batch records and master data

Collaborate with cross-functional teams (Manufacturing, Automation, IT, and QA) to translate user requirements into functional MES workflows

Participate in the validation, approval, and change control processes for MES recipes and data

Support hypercare activities post-PAS-X implementation and provide ongoing troubleshooting

Conduct SME and user training to ensure effective adoption and compliant system use

Prepare and update system documentation aligned with GMP, Part 11, and data integrity requirements

Provide guidance on best practices in MES governance and system improvements

Act as a subject matter expert in integrating MES with upstream/downstream systems (e.g., LabX, OSI PI)

Required Qualifications

Bachelors degree in Engineering (Mechanical, Electrical, Computer, or Chemical) or equivalent experience

Minimum 10 years of experience in automation or process control in the life sciences industry

At least 5 years of hands-on experience with Korber PAS-X MES Suite

Strong understanding of GxP, FDA/ICH regulations, Part 11 compliance, and SDLC methodology

Proficiency in MS Office, HP ALM, or similar validation tools

Proven skills in cross-functional collaboration, issue resolution, and project documentation

Excellent communication and organizational skills

Preferred Qualifications

Experience with computer system validation (CSV) across enterprise platforms

Familiarity with Mettler Toledo LabX and Aveva OSIsoft PI

Demonstrated leadership in MES deployment within GMP environments

Knowledge of GxP change control and impact assessments

Why Join Us

This role offers the chance to make a measurable impact in a company driven by scientific innovation and dedicated to transforming lives. Work alongside top professionals in biotechnology to implement systems that ensure the quality and reliability of life-changing therapies.

Ready to take the next step in your MES career within a global biopharmaceutical leader? Apply now to join a passionate team shaping the future of digital manufacturing.