Automation Engineer - QBMS
Automation Engineer - QBMS
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Job Description
Job Title: Automation Engineer QBMS
Location: Toulouse
Department: : Automation
Reports To: Sr Automation Engineer
About Us: this is who we are
At Just Evotec Biologics we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team we thrive on challenging the status quo learning from each other and pushing the boundaries of whats possible. Were on a mission to create a place where curiosity isnt just encouragedits celebrated.
Are you someone who asks questions seeks answers and isnt afraid to go deeper #BeCUREious with us and see where your curiosity can take you!
The Role: Your challenge in our journey
Were looking for a passionate and curious Automation Engineer QBMSto join our team. If youre excited by new challenges solving complex problems and learning every step of the way you might just be the perfect this role youll have the opportunity to drive impactful projects collaborate with bright minds and explore uncharted territories.
As a Automation Engineer QBMS at Just Evotec Biologics youll have the freedom to ask the hard questions think outside the box and find creative solutions that push us forward. Its a role where your curiosity will fuel both your personal growth and the success of the team.
The Automation Engineer will be part of the JPOD2 Automation team in the MTS/MSAT department. The incumbent will serve as the site-level lead for the configuration implementation validation and lifecycle management of the site Building Management Systems for a clinical and commercial manufacturing site at the Toulouse manufacturing facility. The successful candidate will have demonstrated proficiency in Automation and Instrumentation Design and Validation Systems integration using industry standard protocols (BACnet Profinet OPC Hart) 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.
What Youll Do:
- Serve as the site-level lead or support for the configuration implementation validation and lifecycle management of the site Building Management Systems.
- Support the definition of equipment and User Requirements
- Support the Design and Development of the Building Automation Solutions
- Evaluate new equipment and new technologies prior to implementation
- Maintain compliance with company standards.
- Define maintenance requirements and spare parts management
- Participate in impact assessment for equipment/system failures
- Develop and implement lifecycle documentation for the BMS system including user requirements design and functional specifications SOPs training documents etc.
- Collaborate with the validation team for the initial and ongoing qualification of the QBMS system and related instrumentation. Ensure full regulatory compliance including requirements for GMPs and data integrity.
- Provide on-demand technical support including troubleshooting and issue resolution related to Automation system infrastructure configuration and interfaces to support operational requirements.
- Lead or contribute to technical root cause analysis incident investigations and troubleshooting of process control issues.
- Provide project oversight on BMS implementation projects contracted to vendors or 3rd party suppliers/integrators.
Who You Are:
- Automation Engineering Electrical Engineering Computer Science Chemical Engineering Biotech Engineering or related life science engineering.
- Experience with PCVue Siemens PLC TIA Portal platforms
- 5 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 skills
- Demonstrated skills coding in Siemens Platforms (TIA Portal)
- Demonstrated skills developing HMI and SCADA (PCVue WinCC)
- Demonstrated skills designing and integrating instrumentation in BMS
- 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
- 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 DeltaV
Proficiency developing and executing CSV plans and protocols
Why Join Us:
- Growth Opportunities: Were a company that believes in continuous learning and development. Whether its professional courses mentorship or new projects well help you grow.
- Flexible Work Environment: We offer flexible work options to help you balance your professional and personal life.
- Inclusive Culture: Were committed to building a diverse and inclusive environment where everyones voice is valued and curiosity is encouraged.
- Innovative Projects: Youll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
- A Place for Big Ideas: We dont just talk about thinking outside the boxwe throw the box away. If youve got ideas we want to hear them.
Are You Still Curious
If youve read this far then chances are youve got a curious mindjust like us. So what are you waiting for Take the leap and apply today. We cant wait to see where your curiosity leads youand how it will shape the future of Just Evotec Biologics.
Let your curiosity guide your career#BeCUREious and explore the endless possibilities at Just Evotec Biologics !
FR : Dans le cadre de sa politique Diversit Evotec tudie comptences gales 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.
Employment Type
Full-Time
