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Lead Automation Engineer
2 months ago
Just-Evotec Biologics is on the lookout for a dedicated Senior Automation Engineer with a passion for enhancing global access to biotherapeutics. Automation in processes is fundamental to Just's manufacturing capabilities. This position is part of the Automation team within Global MSAT, tasked with establishing the automation (DeltaV) standards for the J.POD Manufacturing platform and ensuring consistency across the J.POD network. The role also involves providing automation support to Just-Evotec's manufacturing facilities.
The successful candidate will be expected to devise and implement innovative solutions to intricate technical challenges, contributing to Just's vision of a novel, flexible, and reconfigurable cGMP manufacturing facility focused on continuous processing. A strong proficiency in DeltaV process control automation (SCADA and DCS) used for bioprocessing control is essential, along with some familiarity with other automation platforms (e.g., Siemens, Allen-Bradley, Wonderware). Experience in a GMP environment, change control, and automation validation according to GAMP5 guidelines is highly desirable.
Travel Requirements & Flexibility:
This role may require occasional travel to other sites. Additionally, flexibility in working hours will be necessary to effectively collaborate with colleagues across various time zones.
Key Responsibilities:
- Engage in the design and implementation of automation and process control strategies to enhance the JPOD continuous manufacturing platform, including batch tracking, establishing process control limits, and applying predictive control algorithms.
- Maintain a globally validated DeltaV library and define governance and change management protocols for the DeltaV platform to ensure alignment across the manufacturing network.
- Contribute to the development of a global software development life cycle (SDLC) and roadmap for DeltaV.
- Collaborate with Site MSAT Automation teams to support both global and site-specific objectives.
- Develop or refine detailed specifications, qualification (IQ/OQ/PQ), engineering, SOP, and training documentation.
- Work alongside various disciplines, including manufacturing, process engineering, process development, data science, utility operations, maintenance, quality assurance, and validation to implement operational enhancements.
- Author and execute test scripts or validation protocols.
- Lead or assist in technical root cause analysis, incident investigations, and troubleshooting of process control challenges.
- Provide technical assistance to manufacturing sites as needed, specifically regarding process control and automation infrastructure.
- Oversee or drive progress on PAS implementation projects contracted to third-party suppliers/integrators with guidance from team leadership.
- B.S or M.S. in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or a related field.
- 5+ years of relevant experience in the pharmaceutical, biotech, or life sciences sectors.
- Strong background in control system automation, including design, installation, programming, and validation of automated processes.
- Familiarity with FDA CFR 21 Part 11 compliance.
- Proven track record of successful project completions utilizing established engineering and project management skills.
- Demonstrated coding skills in DeltaV.
- Strong focus on quality and attention to detail.
- Self-motivated with excellent organizational skills.
- Strong interpersonal, teamwork, and communication skills are essential.
- Excellent oral and written communication abilities.
- Experience in computer software validation.
- Participation in global teams or Centers of Excellence.
- Utilization of GAMP5 risk-based approaches when implementing changes to validated PAS.
- Involvement in authority inspections or audit support.
- Experience with single-use technologies and systems.
- Familiarity with Siemens, Allen-Bradley, and Wonderware automation platforms.
Just-Evotec Biologics is an Equal Opportunity Employer, ensuring that all qualified applicants receive consideration for employment without regard to race, gender, age, disability, genetic information, gender expression, gender identity, national origin, religion, sexual orientation, or veteran status.
