Senior EBR Consultant
Senior EBR Consultant
Posted on :
18-05-2025
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1 Vacancy
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Job Description
Who we are
Aizonis a softwareasaservice provider that transforms manufacturing operations in life science industries using advanced analytics and artificial intelligence.
Following our recent Series C round of growth funding we are looking for ambitious new team members motivated to directly impact our future growth and success as we launch what we consider Aizon 3.0. Aizon is helping pharma manufacturers and CDMOs make better decisions in GMP operations.
What makes us different from other manufacturing platforms We help operations leaders and engineers avoid endless cycles of chasing data in disparate and heavyhanded systems and rapidly understand how to run their manufacturing processes better.
Were solving multiple problems in GMP operations that cost manufacturers millions yearly while accelerating their digital maturity journey. One of our unique capabilities is the ability to operationalize the use of predictive AI models in realtime without a big data science staff.
Were backed by both industry and software investor firms like NewVale Capital Atlantic Bridge Danaher Honeywell CrossLink and UnCork with solid industry and technology expertise.
Our mission is to improve global health by optimizing how medicines are manufactured so that pharma and biotech companies can provide patients worldwide with the right medicine at the right time and price.
Join us if you are motivated to directly impact our companys success and growth path forward and more importantly by positively contributing to the life science industry and deserving patients worldwide.
The Position
Reporting to the Electronic Batch Record (EBR) Consulting Team Leader the EBR Consultant will inspire our customers through technology using his/her growing knowledge of EBRs Pharma industry processes and regulations GXP Compliance Cloud Computing and Software as a Service. He/She will provide consulting services to clients in the pharmaceutical biotechnological and related industries on the implementation of Aizons EBR software solution (Execute) to ensure its successful adoption and satisfaction for our clients.
Responsibilities
- Provide consulting services to clients on the implementation and best use of Aizons EBR software solution (Execute).
- Being part of the projects and Proofs of Value as assigned by the company and keeping in touch with clients.
- Deliver training on Execute to clients
- Conduct a gap assessment of clients current Master Batch Recipes (MBR).
- Based on the results of the gap assessment design the best conversion strategy and sequence lead and/or coordinate the developers team which is going to convert the existing MBRs file into the Execute format.
- Follow and fulfill the Aizon Compliance teams directions to ensure adherence to GxP regulations in the delivery of the consultancy tasks.
- Support Aizon Compliance teams when needed in the preparation of the project documentation testing evidence validation requirements etc.
- Detect opportunities for new business.
- Provide presales support on demand.
- Work collaboratively with solution architects/data engineers quality engineers usability experts support engineers and clients to improve the Execute software solution and its associated implementation services.
- Collaborate with the EBR Consulting Team Leader in the definition of best practices and learnings which will help to optimize and improve the delivery of future projects.
- Design and map the functional information to integrate/interchange between Execute and other client systems (ERP etc..).
- Do any other consultancy tasks related to the EBR implementation as required to ensure the success of the project.
- Get a good domain of the other Aizon solutions beyond the EBR one (Execute) such as: Unify Predict.
Qualifications:
- Musthave
- Excellent educational background (minimum MSc) in Pharmaceuticals Biotechnology Chemistry Engineering or Computer Science.
- At least 3 years in a similar position (customerfacing participating in projects with clients)
- 5 years of experience in the pharmaceutical biotechnology or other regulated industries with special emphasis on the manufacturing processes.
- Strong understanding of GxP FDA and other global regulatory requirements for EBRs.
- Excellent communication and interpersonal skills
- Ability to work independently and as part of a team
- Ability to meet deadlines and deliver highquality work
- Ability to understand business requirements and translate them into software configuration requirements
- Availability to travel for visiting clients is required.
- Proficiency in spoken and written English.
- 3 years of experience in the implementation or validation of EBRs
- Previous experience in Computer Systems Validation and/or Pharma Validation departments.
- Experience with integration of systems and technologies including Manufacturing Execution Systems (MES) Laboratory Information Management Systems (LIMS) Enterprise Resource Planning (ERP) Systems Quality Management Systems (QMS) and/or SCADA systems.
- A decent understanding of programming principles and techniques.
- Working proficiency both spoken and written in additional languages besides English.
Nice have
Skills
- Strong analytical and creative problemsolving skills
- Team player collaborative innovative get things done mind
- Capable of working with a dynamic product that is everchanging and evolving rapidly
- Ability to work under pressure responsible for multiple vital tasks in parallel
- You take responsibility for the success of the project
- Excellent clientfacing and internal communication skills
- Accustomed to working with Tech Sales teams as well as with Solutions Architects
What We Offer
Unique opportunity to join our company as it scales with great market traction and huge potential to continue growing
Competitive salary in the sector and scheduled performance/salary reviews
Stock Options
Private Medical & Dental Insurance
Internal Training & Certifications
Professional development and collaborative environment
Flexible schedule & Intensive Fridays
Flexible Remuneration Options
Language Training Courses
Topnotch tech pack We are Mac lovers!
Monthly Team Building Activities
We are committed to providing an inclusive environment where all employees feel mutual respect and are contributing to the good of society. We are a group of creators with diverse backgrounds (over 27 different citizenships in our company) and are proud to be an equal opportunity workplace. All employment is decided based on qualifications merit and business needs. If you need assistance or accommodation due to a disability you may contact us at
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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