Process Automation Engineer– Process Automation System (all genders)
Process Automation Engineer – Process Automation System (PAS) (all genders) | Toulouse, France
Just-Evotec Biologics is seeking a motivated Process Automation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. The Process Automation Engineer will be part of the Process Engineering team in the Manufacturing Science and Technology (MSAT) department. The incumbent will serve as the site-level lead for the configuration, implementation, validation, and lifecycle management of the site Process Automation System (PAS) for use in clinical and commercial manufacturing at the Toulouse J.POD manufacturing facility. The successful candidate will have demonstrated proficiency in PAS deployment and system administration, integration of PAS with related business and automation systems, and an understanding of ISA-95 Operational Technology architecture. Experience working in a GMP environment, change control, and software validation in accordance to GAMP5 guidelines is required.
Responsibilities:
Serve as the site-level lead for the configuration, implementation, validation, and lifecycle management of the site Process Automation System (PAS)
Collaborate with site and global teams for the development and implementation of PAS system life cycle strategy and business/technical processes. Leverage existing solutions and develop further enhancements of the PAS solution for J.POD manufacturing as a platform and ensure alignment across the J.POD manufacturing network.
Maintain compliance with company standards for active directory, network configuration and cybersecurity.
Lead or support integration of PAS with associated systems such as MES (PAS-X), Data Historian (AVEVA PI), ERP (SAP), LIMS (LabWare), etc.
Develop and implement lifecycle documentation for the PAS system including user requirements, design and functional specifications, SOPs, training documents, etc.
Support the New Product Introduction (NPI) process by collaborating with stakeholders to translate manufacturing process requirements and PAS system best practices to design and implement PAS recipes via the quality system change control process to support manufacturing operations.
Develop and implement PAS system updates via the quality system change control process to support introduction of new manufacturing equipment, manufacturing process improvements, and lifecycle management of software and hardware systems.
Collaborate with the validation team for the initial and ongoing qualification of the PAS system and the equipment it controls. Ensure full regulatory compliance including requirements for GMPs and data integrity.
Manage the system to deliver optimal performance and reliability for process systems and equipment to support commercial manufacturing operations.
Provide on-demand technical support including troubleshooting and issue resolution related to PAS system infrastructure, configuration and interfaces to support manufacturing operational requirements.
Lead or contribute to technical root cause analysis, incident investigations, and troubleshooting of process control issues.
Provide project oversight on PAS implementation projects contracted to vendors or 3rd party suppliers/integrators.
Position Requirements:
B.S. or M.S. in Electrical Engineering or Computer Science, Chemical Engineering, Biotech Engineering or related life science engineering.
7+ years relevant experience in pharmaceutical, biotech, or life sciences with 5+ years of experience with current Good Manufacturing Practice (cGMP) regulations
Strong control system automation background including design, installation, programming and validation of automated processes
Working knowledge of cGMP manufacturing and regulatory regulations and requirements (FDA CFR 21 Part 11 and EMA Annex 11) for biologics/pharmaceuticals
Leverage experience of Good Automated Manufacturing Practice (GAMP) framework for risk-based approach to computer system validation
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
Good interpersonal, team, and communication skills are a must
Excellent oral and written communication skills in both English and French
Additional Preferred Qualifications:
Experience in computer software validation in both writing test scripts and executing test protocols is strongly preferred
Experience using GAMP5 risk-based approach when implementing changes to validated software systems
Experience in supporting audits and inspections by health authorities and other external auditors
Experience with single-use technologies and systems
Experience with Wonderware, Allen Bradley, Wonderware automation platforms
Proficiency developing and executing CSV plans and protocols
About Just-Evotec Biologics
Just – Evotec Biologics, wholly-owned by Evotec SE, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just-Evotec Biologics team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Just’s focus is to create access and value for a global market through scientific and technological innovation. This position will be located at our newly built state-of-the-art labs and J.POD® commercial manufacturing facility in Toulouse.
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.
