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MES/Automation Engineer/Sr. Engineer – Technical Operations

Employer
Just - Evotec Biologics
Location
Redmond, WA
Start date
Aug 10, 2022

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Discipline
Engineering, Automation Engineer, Manufacturing & Production
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioForest
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Job Details

Just.Bio is seeking a motivated and creative MES/Automation Engineer/Sr. Engineer that desires a significant opportunity toimprove worldwide access to biotherapeutics. The MES/Automation engineer will be part of the Manufacturing Automation team in the Technical Operations organization to support the management and expansion of the PAS-X Manufacturing Execution System used for clinical and commercial manufacturing at Just-Evotec Biologics. The successful candidate will have demonstrated proficiency in MES deployment and configuration as well as MES integration with related business and automation systems such as Level 4/ERP and Level 2/PCS. Experience with biologics manufacturing processes in a GMP environment, change control, and software validation in accordance to GAMP5 guidelines is highly preferred.

Responsibilities (including but are not limited to):

  • Collaborate with key stakeholders and provide significant input and guidance in identifying and implementing MES domain and functional domain solutions for clinical and commercial manufacturing
  • Translate process requirements and MES system best practices into practical, usable electronic batch records (MBR recipe design)
  • Apply risk-based approach to develop design requirements and support computer system validation strategy
  • Lead or support integration of MES with external systems such as process control systems (DeltaV), lab equipment and instruments, and other electronic systems (ERP, LIMS, etc.)
  • MES system configuration, programming, testing, and troubleshooting
  • Author design documents (configuration, software design specifications) and validation protocols
  • Develop business processes, guidelines, SOPs, and training for the MES system
  • Support MES system life cycle, expansion strategy, and business/technical process change management
  • Participate in internal and external audits/inspections

Position Requirements:

  • B.S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.
  • 7+ years of MES experience in Pharmaceutical, Biotech, or Life Sciences industries with 5+ years of experience with current Good Manufacturing Practice (cGMP) Regulations
  • Working knowledge of cGMP manufacturing and regulatory regulations and requirements for biologics/pharmaceuticals
  • Knowledge and application of ANSI/ISA-88 (process control) and ANSI/ISA-95 (automated interfaces) standards
  • Knowledge and application of IT infrastructure and applications (server virtualization, security, wireless communication protocols, firewalls, etc.)
  • Demonstrated ability to work independently and collaboratively on cross-functional teams.

Additional Preferred Qualifications:

  • Previous experience in computer software validation coordinating activities with IT, QA, Warehouse, and Manufacturing
  • Leverage expertise using GAMP5 guidelines for risk-based approach to computer system validation
  • Applies knowledge and expertise to solve complex technical problems
  • Authority inspection or audit support involvement
  • Experience with a manufacturing process that utilizes single-use technologies and systems
  • Experience using DeltaV
  • Experience using PAS-X
  • Proficiency developing and executing CSV plans and protocols


Worker

Company

Just - Evotec Biologics, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio.

Find Us
Phone
206-651-5094
Location
401 Terry Avenue North
Seattle
98109
US
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