Pharma MES & MBR Consultant
Who we are
Aizon is a software-as-a-service 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 heavy-handed systems and rapidly understand how to run their manufacturing processes better.
- We’re 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 real-time without a big data science staff.
- We’re backed by both industry and software investor firms like NewVale Capital, Atlantic Bridge, Danaher, Honeywell, CrossLink, and UnCork, with solid industry and technology expertise.
Join us if you are motivated to directly impact our company's success and growth path forward and, more importantly, by positively contributing to the life science industry and deserving patients worldwide.
The Position
Reporting to: Sr. EBR Consultant & Practice Leader
The Pharma MES & MBR Consultant will inspire customers through technology, using growing knowledge of EBRs, pharmaceutical industry processes and regulations, GxP compliance, cloud computing, and Software as a Service. The consultant will provide consulting services to clients in the pharmaceutical, biotechnological, and related industries on the implementation of Aizon’s EBR software solution (Execute) to ensure its successful adoption and client satisfaction.
Responsibilities
- Provide consulting services to clients on the implementation and best use of Aizon’s 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 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 developer's team that is going to convert the existing MBRs file into the Execute format.
- Follow and fulfill Aizon Compliance team 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 pre-sales 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 task 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 and Predict.
- Excellent educational background (minimum MSc) in Pharmaceuticals, Biotechnology,, Chemistry Engineering or Computer Science.
- At least 3+ years in a similar position (customer-facing, participating in projects with clients)
- 3+ 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 high-quality 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.
- Willing to comply with and follow all regulations required when working in a highly regulated environment, such as ISO standards and GMP regulations.
- 5+ 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.
- Strong analytical and creative problem-solving skills.
- Team player, collaborative, innovative, and results-driven.
- Capable of working with a dynamic product that is ever-changing 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 client-facing and internal communication skills.
- Accustomed to working with Tech Sales teams as well as with Solutions Architects.
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