Senior Manager, Digital Systems Site MSAT - Redmond, WA

Senior Manager, Digital Systems Site MSAT

Just-Evotec Biologics is seeking a motivated Sr. Manager, Digital Systemsthat desires a significant opportunity to improve worldwide access to biotherapeutics. Process automation is a cornerstone of Just’s manufacturing technology. This role is responsible for leading the Automation, Digital Systems Team in Site MSAT. 

This role is responsible for defining the site automation support strategy, lead the team in maintaining site automation infrastructure and in providing automation supportto Just-Evotec’s US manufacturing sites. This role will also work with the global MSAT team in maintaining automation (Delta V) recipes for the J.POD Manufacturing platform and to ensure alignment across the J.POD network. 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 is expected to have advanced proficiencyof DeltaVprocess control automation(SCADA, DCS)and in MES (Manufacturing Execution Systems)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 expected.

Responsibilities (including but are not limited to):

• Lead the Site Automation Team. Responsible for recruitment and employee development in the automation organization. 

• Lead the design and implementation of automation and process control schemes to NPI processes, batch tracking, establishing process control limits, and applying predictive control algorithms.

• Define site automation support strategy and site roadmap for Delta V, MES, and other process digital systems. 

• Maintainsite level validated DeltaV library and lead site level governanceand change managementsystem for GMP changes and NPI implementation

• Participate in engagement with global MSAT Automation teamsto support global and site objectives

• Define strategy for development and optimization of automation engineering documents, specifications, SOP, change controls 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

• Provide digital systems project oversight to 3rd party suppliers/contractors. 

• Provide guidance to the team in deviation investigation, technical root cause analysis, and troubleshooting of process control issues. 

• Establish implementation plan and tracking methodology of NCs, CAPAs and change controls to meet site operational needs. 

• Provide leadership to automation representative 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

Position Requirements:

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

• 10+ 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

• Experienced in deviation investigations, technical root cause analysis, troubleshooting of process control issues and CAPAs/Change controls implementation.

• Established record of successful project completions employing proven engineering and project management skills

• Demonstrated skills coding in DeltaV and possess Delta V network knowledge. 

• Demonstrated skills in designed batch records in PASX

• Authority inspection or audit support involvement

• Strong focus on quality and attention to detail 

• Motivated, self-starter with strong organizational skills

• Good interpersonal, team, and communication skills are a must,Excellent oral and written.

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

• Experience with single-use technologies and systems

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 $112,560 to $154,100;  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.