Process Automation Engineer– Process Automation System

il y a 3 semaines

Toulouse, France Just Evotec Biologics EU Temps plein

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.

  • Process Automation Engineer M/F/D

    il y a 5 jours

    Toulouse, Occitanie, France Evote Temps plein

    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...

  • Senior Automation Engineer Process Design

    il y a 5 jours

    Toulouse, Occitanie, France Evote Temps plein

    Senior Automation Engineer, Process Design (all genders)| Toulouse, FranceJust Evotec Biologics is seeking a motivated and creative Senior Scientist or Engineer who desires a significant opportunity to improve worldwide access to biotherapeutics. This position will join a collaborative and multidisciplinary scientific team within the Process Design group to...

  • Process Automation Engineer

    il y a 5 jours

    Toulouse, Occitanie, France Evote Temps plein

    Process Automation Engineer – Data Historian (all genders) | Toulouse, FranceJust-Evotec Biologics is seeking a motivated and creative 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...

  • Senior Automation Engineer Process Design

    Il y a 2 mois

    Toulouse, France Evotec Temps plein

    Senior Automation Engineer, Process Design (all genders) | Toulouse, France Just Evotec Biologics is seeking a motivated and creative Senior Scientist or Engineer who desires a significant opportunity to improve worldwide access to biotherapeutics. This position will join a collaborative and multidisciplinary scientific team within the Process Design...

  • Process Automation Engineer

    Il y a 2 mois

    Toulouse, France Evotec Temps plein

    Process Automation Engineer – Data Historian (all genders) | Toulouse, France Just-Evotec Biologics is seeking a motivated and creative 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...

  • Process Automation Engineer

    il y a 4 semaines

    Toulouse, France Just Evotec Biologics EU Temps plein

    Process Automation Engineer – Data Historian (all genders) | Toulouse, France Just-Evotec Biologics is seeking a motivated and creative 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...

  • Process Automation Engineer

    il y a 3 semaines

    Toulouse, France Just Evotec Biologics EU Temps plein

    Process Automation Engineer – Data Historian (all genders) | Toulouse, France Just-Evotec Biologics is seeking a motivated and creative 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...

  • Senior Automation Engineer

    il y a 2 semaines

    Toulouse, France RED Global Temps plein

    Automation Expert with Pharma company - 12 months contract - On SiteMy client is a leading provider in the pharmaceutical industry, specializing in the production and development of vaccines. They are looking for an Automation Specialist/Expert to work on a contract basis. The successful candidate will deliver expertise in automation systems, particularly...

  • Principal Engineer, Automation

    il y a 5 jours

    Toulouse, Occitanie, France Danaher Corporation Temps plein

    Be part of something altogether life-changingWorking at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...

  • Principal Engineer, Automation

    il y a 2 semaines

    Toulouse, Occitanie, France Danaher Corporation Temps plein

    Be part of something altogether life-changingWorking at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...

  • Automation & Integration Engineer (f/m/d)

    il y a 5 jours

    Toulouse, Occitanie, France InFactory Solutions GmbH Temps plein

    Automation & Integration Engineer (f/m/d) Full-timeWho we areInFactory Solutions GmbH (InFy) is a 100% Airbus subsidiary, part of Testia Group, located in the Munich Area. InFy develops solutions forautomated quality inspection of aircraft components during manufacturing.Our multidisciplinary team groups competence fields from software, mechanical, and...

  • Electronic Design Automation Engineer

    Il y a 2 mois

    Toulouse, Occitanie, France CELAD Temps plein

    Nous poursuivons notre développement et recrutons un(e) Electronic Design Automation Engineer (F/H) pour intervenir sur un projet dans le secteur des semi-conducteurs à Toulouse. Voici un aperçu détaillé de vos missions :Évaluer et valider les solutions EDA (Electronic Design Automation) des fournisseurs visant à automatiser les différentes phases...

  • Electronic Design Automation Engineer

    il y a 3 semaines

    Toulouse, Occitanie, France CELAD Temps plein

    Nous poursuivons notre développement et recrutons un(e) Electronic Design Automation Engineer (F/H) pour intervenir sur un projet dans le secteur des semi-conducteurs à Toulouse. Voici un aperçu détaillé de vos missions :Évaluer et valider les solutions EDA (Electronic Design Automation) des fournisseurs visant à automatiser les différentes phases...

  • Electronic Design Automation Engineer

    il y a 3 semaines

    Toulouse, France CELAD Temps plein

    Nous poursuivons notre développement et recrutons un(e) Electronic Design Automation Engineer (F/H) pour intervenir sur un projet dans le secteur des semi-conducteurs à Toulouse. Voici un aperçu détaillé de vos missions 🎯 :-          Évaluer et valider les solutions EDA (Electronic Design Automation) des fournisseurs visant à automatiser...

  • Electronic Design Automation Engineer

    Il y a 2 mois

    Toulouse, France CELAD Temps plein

    Nous poursuivons notre développement et recrutons un(e) Electronic Design Automation Engineer (F/H) pour intervenir sur un projet dans le secteur des semi-conducteurs à Toulouse. Voici un aperçu détaillé de vos missions 🎯 :-          Évaluer et valider les solutions EDA (Electronic Design Automation) des fournisseurs visant à automatiser...

  • Electronic Design Automation Engineer

    Il y a 2 mois

    Toulouse, France CELAD Temps plein

    Description du poste Envie d’un nouveau challenge… CELAD vous attend ! ✨ Nous poursuivons notre développement et recrutons un(e) Electronic Design Automation Engineer (F/H) pour intervenir sur un projet dans le secteur des semi-conducteurs à Toulouse. Voici un aperçu détaillé de vos missions : Évaluer et valider les...

  • Electronic Design Automation Engineer

    Il y a 2 mois

    Toulouse, France CELAD Temps plein

    Description du poste Envie d’un nouveau challenge… CELAD vous attend ! ✨ Nous poursuivons notre développement et recrutons un(e) Electronic Design Automation Engineer (F/H) pour intervenir sur un projet dans le secteur des semi-conducteurs à Toulouse.Voici un aperçu détaillé de vos missions :Évaluer et valider les solutions EDA (Electronic...

  • Process Engineer

    Il y a 2 mois

    Toulouse, France Evotec Temps plein

    Just-Evotec Biologics is seeking a highly motivated Upstream Process Engineer - New Product Introduction (NPI) to join a fast-paced, collaborative, and multidisciplinary team to lead activities related to the introduction of new products to the J.POD Toulouse biotherapeutics manufacturing facility. The role will provide cross-functional interactions for all...

  • Process Engineer

    Il y a 2 mois

    Toulouse, France Evotec Temps plein

    Just-Evotec Biologics is seeking a highly motivated Downstream Process Engineer - New Product Introduction (NPI) to join a fast-paced, collaborative, and multidisciplinary team to lead activities related to the introduction of new products to the J.POD Toulouse biotherapeutics manufacturing facility. The role will provide cross-functional interactions for...

  • Process Engineer

    il y a 3 semaines

    Toulouse, France Just Evotec Biologics EU Temps plein

    Just-Evotec Biologics is seeking a highly motivated Downstream Process Engineer - New Product Introduction (NPI) to join a fast-paced, collaborative, and multidisciplinary team to lead activities related to the introduction of new products to the J.POD Toulouse biotherapeutics manufacturing facility. The role will provide cross-functional interactions for...