Job Openings

Sr. MES Engineer - Werum PAS/X

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Location
Oceanside, CA
Job Type
Direct Hire
Date
Jul 09, 2019
Job ID
2673744

The Senior MES Engineer will be part of a team that will serve as System Owner of the Manufacturing Execution System (MES) for  Viral Vector Manufacturing Facility in Oceanside, CA. The successful candidate will have demonstrated proficiency in leading MES deployment and system administration, implementing complex electronic Manufacturing Batch Records and integration of MES with related business and automation systems.


 


Responsibilities (including but are not limited to):



  • Translate process requirements and MES system best practices into practical, usable electronic batch records
  • Develop design requirements, functional specifications, and support computer system validation strategy
  • Participate in the development of global standards for batch record design, integration with process/test equipment and other electronic business and automation systems
  • Collaborate with vendors (as part of a team) to define user requirements and ensure the system design meets business requirements
  • Develop business processes, guidelines, Work Instructions and SOPs to support the MES systems
  • Provide leadership to a cross-site, multi-functional (MES Center of Excellence (CoE), IT, Quality, Supply Chain, Manufacturing, Process Development, etc.) collaboration to implement MES
  • Partner with internal departments & external vendors to assist in commissioning MES system.
  • Document requirements, process flows, new functionality, and creation of SOP/training materials while maintaining all materials and configured software in a central repositories
  • Participate in the development of MES system life cycle strategy and business/technical processes for change management
  • Training super and end users on functionality and process changes as they relate to MES
  • Travel as required to participate in technical meetings (Approximately 10%)
  • Available for 24/7 support (scheduled and off hours)
  • Trouble shooting daily operational system issues to define root cause, working in collaboration with Manufacturing, Quality and CoE to build temporary/permanent solutions
  • Administration and maintenance of site MES Production and offline systems

 


Candidate Qualifications:



  • Demonstrates knowledge of new product introduction and tech transfer
  • Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals
  • Knowledge of cell culture or cell therapy manufacturing technical support
  • Knowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing
  • Knowledge and application of ANSI/ISA-88 (process control) and ANSI/ISA-95 (automated interfaces) standards
  • Knowledge and application of Good Automated Manufacturing Practice (GAMP) framework for risk-based approach to computer system validation
  • Knowledge and application of IT infrastructure and applications (server virtualization, security, wireless communication protocols, firewalls, etc.)

 


Experience:


10+ years of experience in Pharmaceutical, Biotech or Cell Therapy industries


5+ years of experience with current Good Manufacturing Practice (cGMP) Regulations


5+ years of experience with industry recognized Manufacturing Execution System (MES)


2+ years of experience with Werum PAS-X MES Generic Master Batch Record (GMBR) Design and System Administration (Preferred)


 


Education and Certifications:


Bachelors’ Degree in Engineering, Computer Science, or equivalent industry experience


Lean Six Sigma Green Belt or higher (preferred)


Project Management Professional (PMP) (preferred)