Automation/Process Controls Engineer

Evotec; Toulouse; Sur place; EUR 55 000 - 90 000; Plein temps

Résumé du poste

Une entreprise innovante recherche un ingénieur en automatisation des processus passionné par l'amélioration de l'accès mondial aux biothérapeutiques. Dans ce rôle, vous serez responsable de la gestion du système d'automatisation des processus sur le site de fabrication à Toulouse. Vous travaillerez en étroite collaboration avec des équipes locales et mondiales pour garantir la conformité aux normes de fabrication et aux exigences réglementaires. Si vous avez une solide expérience en automatisation, en gestion de projet et en conformité GMP, cette opportunité est faite pour vous. Rejoignez une équipe dynamique et contribuez à des projets qui font la différence dans le domaine des biotechnologies.

Qualifications

• 8+ ans d'expérience dans l'industrie pharmaceutique ou biotechnologique.
• Connaissance des réglementations cGMP et des exigences de validation logicielle.

Responsabilités

• Gérer la configuration et la validation du système d'automatisation des processus.
• Collaborer avec les équipes pour développer des stratégies pour le cycle de vie du système PAS.

Connaissances

Automatisation des systèmes

Gestion de projet

Communication

Résolution de problèmes

Connaissance des GMP

Programmation DeltaV

Attention aux détails

Compétences interpersonnelles

Formation

B.S. ou M.S. en ingénierie électrique

Ingénierie chimique

Ingénierie biotechnologique

Outils

DeltaV

Wonderware

Allen Bradley

SAP

LIMS (LabWare)

MES (PAS-X)

AVEVA PI

Description du poste

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:

• Perform 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.
• Support integration of PAS with associated systems such as MES (PAS-X), Data Historian (AVEVA PI), ERP (SAP), LIMS (LabWare), etc.
• Support in the lifecycle of the 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.
• Support control system integration between DCS and Skids 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.
• 8+ years relevant experience in pharmaceutical, biotech, or life sciences with 3+ 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 automation platforms
• Proficiency developing and executing CSV plans and protocols