Evotec SE-posted 2 months ago
$112,560 - $154,100/Yr
Full-time • Mid Level
Redmond, WA
1,001-5,000 employees
Chemical Manufacturing

At Just Evotec Biologics, we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what's possible. We're on a mission to create a place where curiosity isn't just encouraged-it's celebrated. This role is part of the Automation team in Global MSAT that is responsible for defining the automation (DeltaV) standards for the J.POD Manufacturing platform and ensuring alignment across the J.POD network, as well as provide automation support to Just-Evotec's manufacturing sites. This includes designing and implementing creative solutions to complex technical challenges in helping Just achieve a novel flexible and reconfigurable cGMP manufacturing facility focused on continuous processing. The role will have an advanced proficiency of DeltaV process control automation (SCADA and DCS) used for bioprocessing control as well as at least some experience in other automation platforms (ie, Siemens, Allen-Bradley, Wonderware, etc.). Experience working in a GMP environment, change control, and automation validation in accordance with GAMP5 guidelines is highly preferred.

  • Participate in the design and implementation of automation and process control schemes to advance the state of the JPOD continuous manufacturing platform including, but not limited to batch tracking, establishing process control limits, and applying predictive control algorithms.
  • Maintain global validated DeltaV library and define the governance and global change management for the DeltaV platform to maintain alignment across the manufacturing network.
  • Participate in defining global software development life cycle (SDLC) and global roadmap for DeltaV.
  • Participate in engagement with Site MSAT Automation teams to support global and site objectives.
  • Develop or improve detailed specification, qualification (IQ/OQ/PQ), engineering, SOP, and training documents.
  • Collaborate with multiple disciplines, including manufacturing, process engineering, process development, data scientists, utility operations, maintenance, quality assurance, and validation to implement operational improvements.
  • Author and execute test scripts or validation protocols.
  • Lead or contribute to technical root cause analysis, incident investigations, and troubleshooting of process control issues.
  • Provide technical support to the manufacturing sites as needed, specific to process control and automation infrastructure.
  • Provide project oversight or drive progress on PAS implementation projects contracted to 3rd party suppliers/integrators with some guidance from team lead.
  • Bachelor's or Master's degree in Engineering, Computer Science, or related field with 5+ years of relevant experience; OR
  • Associate's degree in a science-related field with 8+ years of relevant experience; OR
  • High school diploma or GED with 10+ years of relevant experience.
  • 2+ years in pharmaceutical, biotech, or life sciences industries in a GxP-regulated environment.
  • Strong control system automation background. Design, installation, programming, and validation of automated processes is essential.
  • Understanding of FDA CFR 21 Part 11 compliance.
  • Established record of successful project completions employing proven engineering and project management skills.
  • Demonstrated skills coding in DeltaV.
  • Motivated, self-starter with strong organizational skills.
  • Previous experience in computer software validation.
  • Participation on global teams, Center of Excellence, etc.
  • Leverage expertise using GAMP5 risk-based approach when implementing changes to the validated PAS.
  • Authority inspection or audit support involvement.
  • Experience with single-use technologies and systems.
  • Experience with Siemens, Allen Bradley, Wonderware automation platforms.
  • 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.
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