Sr. Automation Engineer, MES

2 weeks ago

Redmond, United States Evotec Full time
Sr. Automation Engineer, MES - Global MSAT

Just-Evotec Biologics is seeking a motivated and creative Sr. Automation Engineer, MES that desires a significant opportunity to improve worldwide access to biotherapeutics. The Sr. Engineer will be part of the Automation Team in Global MSAT that is responsible for defining the MES standards for the J.POD Manufacturing platform and ensuring alignment across the J.POD network, as well as provide MES automation support to Just-Evotec's manufacturing sites. 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 input and guidance in identifying and implementing MES functional domain solutions and platform for JPOD manufacturing
  • Translate process requirements and MES system best practices into practical, usable electronic batch records (MBR recipe design) and other MES workflows for the JPOD manufacturing platform
  • Maintain global validated MES library and participate in defining the governance and global change management for the MES platform to maintain alignment across the JPOD manufacturing network
  • Apply risk-based approach to develop design requirements and support computer system validation strategy
  • Lead or support integration strategy 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
  • Lead execution of test scripts
  • 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 engagement with Site MSAT teams to support global and site objectives
  • 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.
  • 5+ 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


The base pay range for this position at commencement of employment is expected to be $92,800 to $152, 425; Base salary offered may vary depending on individual's skills, experience and competitive market value. Additional total rewards include discretionary annual bonus, comprehensive benefits to include Medical, Dental and Vision, short-term and long-term disability, company paid basic life insurance, 401k company match, flexible work, generous paid time off and paid holiday, wellness and transportation benefits.

Evotec (US) Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.

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