Automation/Process Controls Engineer - Site MSAT, Redmond, WA
About The Position
About Us: this is who we are 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. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you! The Role: / your challenge, …in our journey 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.
Requirements
- B.S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.
- 4+ years relevant experience in pharmaceutical, biotech, or life sciences
- Strong control system automation background.
- Good understanding of design, installation, programming, and validation of automated processes.
- 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
- Candidate must possess strong focus on quality and attention to detail
- Motivated, self-starter with strong organizational skills
- Occasional travel for global alignment.
- Flexible hours to accommodate collaboration with European teams.
Nice To Haves
- 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
- Experience with MES (Manufacturing Execution Systems)
Responsibilities
- Participate in the design and implementation of automation and process control schemes to NPI processes, batch tracking, establishing process control limits, and applying predictive control algorithms.
- Maintain site level validated DeltaV library and participate at the site level governance and change management system for GMP changes and NPI implementation
- Participate in engagement with global 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.
- Lead CAPAs and change controls, and work closely with the site MTS (Manufacturing technical services) team to implement changes
- Participate as a core team member on the NPI team to ensure all the automation changes/ MES changes are designed/tested as part of NPI readiness.
- Provide technical support to the manufacturing sites as needed, specific to process control and automation systems
Benefits
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
