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Sr. MES Engineer
NPAworldwide Recruitment Network
NPAworldwide Recruitment Network
 
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Job Location: San Diego, CA
JOB DESCRIPTION

Job #: 23908
Title: Sr. MES Engineer
Job Location: San Diego, California - United States
Employment Type:
Salary: $120,000.00 - $180,000.00 - US Dollars - Yearly
Employer Will Recruit From: Nationwide
Must be a Green Card Holder or US Citizen
Relocation Paid?: Yes

WHY IS THIS A GREAT OPPORTUNITY?

Sr. MES Engineer (2 openings) Werum PAS/X awesome opportunity for 2 Sr. MES Engineers in sunny San Diego. New positions! MES is a corporate focus. Will be involved in commissioning MES in this Viral Vector manufacturer. Fast paced environment but casual. Looking for people who collaborate. Will be implementing PAS/X. Must have PAS/X and Life Sciences experience.

JOB DESCRIPTION

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

QUALIFICATIONS

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)




How to Apply:


 
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