Pharma MES & MBR Consultant

Barcelona - Spain

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Who we are

Aizonis 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.

- 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 real-time 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: 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 Aizons 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 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 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 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.

Qualifications: Must - have

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.

Qualifications: Nice - have

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.

Desired Skills

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.

What We Offer

Unique opportunity to join our company as it scales with excellent market traction and huge potential to grow globally

Competitive salary (according to your experience/skills)

Equity bonuses and generous stock options

Flexible schedule - Intensive Fridays

Language one-to-one training courses

Competitive healthcare plans and benefits - Medical & Dental Insurance

Internal training and certifications plan

Flexible Remuneration Options

Career plan and scheduled salary reviews

Monthly team-building activities

Top-notch tech pack We are Mac lovers!

An open and collaborative work environment with a young and dynamic team and a very international culture

An opportunity for personal and professional growth supported by stellar investors and the exciting challenges that come with joining a company at the start of its growth trajectory

Join our team and significantly impact our companys growth and success as we shake the pharmaceutical manufacturing industry. Apply now and be part of our journey to transform the way pharmaceutical companies operate.

We are dedicated to maintaining an inclusive workplace in which all employees are treated with respect and are able to contribute meaningfully to society. Our organization brings together professionals from diverse backgrounds representing more than 28 nationalities and we take pride in being an equal-opportunity employer.

Employment decisions are based exclusively on qualifications merit and business requirements. Applicants who require assistance or accommodation due to a disability may contact us at emailprotected.

Required Experience:

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Who we areAizonis 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...