Senior Automation/Process Control Engineer – Global MSAT /Redmond, WA

Just-Evotec Biologics is seeking a motivated Sr. Automation Engineer, PCS that desires a significant opportunity to improve worldwide access to biotherapeutics. Process automation is a cornerstone of Just’s manufacturing technology. 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 successful candidate 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.

Travel Requirements & Flexibility:

Please note that this position requires occasional travel to our JEB Toulouse site. Additionally, some flexibility in working hours will be necessary to effectively collaborate with our European colleagues across different time zones.

Responsibilities (including but are not limited to):

• 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.

Position Requirements:

• B.S or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering, or related life science engineering.

• 5+ years relevant experience in pharmaceutical, biotech, or life sciences.

• 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.

• Candidate must possess strong focus on quality and attention to detail.

• Motivated, self-starter with strong organizational skills.

• Good interpersonal, team, and communication skills are a must with excellent oral and written communication skills

Additional Preferred Qualifications:

• 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

This job description is intended to describe the general content of the job, and to identify the essential functions of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Because job requirements evolve with the changing needs of Just-Evotec Biologics business, this description is subject to change and may be modified at any time, whether formally or informally.

The base pay range for this position at commencement of employment is expected to be $111,360 to $159,000; Base salary offered may vary depending on the 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.