Automation/Process Controls Engineer/Sr. Engineer – Manufacturing Process Automation
Just.Bio is seeking a motivated Automation/Process Controls Engineer/Sr. Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. Process automation is a cornerstone of Just’s manufacturing technology. The focus of this job is to support process automation systems (PAS) for both clinical and commercial manufacturing. 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 understanding of DeltaV automation used for bioprocessing controls systems (SCADA and DCS) 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 to GAMP5 guidelines is highly preferred.
•Provide system administration and ownership support for DeltaV PAS. Support includes maintaining and managing the following: •Infrastructure and networking architecture
•Migration planning and execution
•Patching, Security and Compliance
•Backup/Restore and Disaster Recovery
•Overall system and hardware reliability
•Design and implement new automation and process control schemes to advance the state of continuous manufacturing including, but not limited to batch tracking, establishing process control limits, and applying predictive control algorithms.
•Develop or improve detailed specification, qualification (IQ/OQ/PQ), engineering, SOP, and training documents.
•Work closely with multiple disciplines, including manufacturing, process engineering, process development, data scientists, utility operations, maintenance, quality assurance, and validation to implement operational improvements.
•Lead or contribute to technical root cause analysis, incident investigations, and troubleshooting of process control issues
•Provide technical support to commercial and clinical manufacturing 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
•BS 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
•Excellent oral and written communication skills
Additional Preferred Qualifications:
•Previous experience in computer software validation
•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