Just-Evotec Biologics is seeking a motivated Sr. Automation/Process Controls Engineer that desires a significant opportunity toimprove worldwide access to biotherapeutics. The primary focus of this job is to lead facility start up activities relating to automation in our flexible and reconfigurable cGMP manufacturing facilities. Process automation is a cornerstone of Just’s manufacturing technology. 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 computer systems validation in accordance to GAMP5 guidelines is highly preferred. The successful candidate must be willing to travel to support Just-Evotec Biologics facility start up project located in Toulouse, France.
- Implement process automation system and infrastructure at Just-Evotec Biologics facilities
- Provide technical expertise to process control automation and infrastructure
- Provide oversight, review and approval for all commissioning and qualification documentation relating to automation activities.
- 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.
- Liaise with Automation team management and have the ability to perform the role with minimal oversight
- Ensure optimal performance and reliability for process systems and equipment.
- Provide technical support to commercial manufacturing as needed, specific to process control and automation infrastructure.
- Troubleshoot and resolve equipment, automation or process issues in the field.
- Provide project oversight 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 in DeltaV coding and configuration
- 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
Additional Preferred Qualifications:
- Experience in computer software validation in both writing test scripts and executing test protocols is strongly preferred
- 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 Wonderware, Allen Bradley, Wonderware automation platforms
Verbal and written communications skills in both English and French