Senior MES Engineer
Senior MES Engineer
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1 Vacancy
Job Description
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.
Employment Type
Full Time
