Produce to Engineering

2 tygodni temu

Wrocław, Województwo dolnośląskie, Polska our future employee Pełny etat 40 000 zł - 80 000 zł rocznie

The position

Joining our company, you will gather an overview of the GBS Enabling Services Organization with a particular focus on the tasks and responsibilities from Validation Management. You are working in a globally operating team that designs, builds and continuously improves Boehringer Ingelheim's global Processes, using agile principles, methods and tools on a daily basis.

You will be qualified to contribute to a cross-functional team, and as a (Senior) Process Specialist, you will be able to coordinate the activities around change requests, performing impact analysis, reviewing, and approving documents and ensuring a validated state of the system.

Tasks & responsibilities
  • Based on your expertise in Computer System Validation, you ensure that process and system changes (demands) are managed according to our validation rules, as well as documenting and analyzing proposed solutions, in close cooperation with experts in our GBS community.
  • You support the execution of business tasks required to deploy approved demands, under the coordination of Release Management.
  • You are responsible for performing and documenting assigned training in a timely manner, in accordance with the curriculum.
  • Your experience in process changes enables you to implement standard processes on time and within budget.
  • Furthermore, you manage the execution and documentation of testing activities.
  • You are familiar with Agile methods and tools, and you actively participate in projects driven by this methodology.
  • You are familiar with working in projects and being measured against Key Performance Indicators (KPIs) / Service Level Agreements (SLAs), striving for continuous improvement.

As a Senior Process Specialist, you additionally take over the following responsibilities:

  • Ensures compliance and validated state of process and systems.
  • Collaborate with the Process Management organization to address process-related inquiries from local Key Users.
  • Together with the Process Management organization, you are responsible for the complete design and maintenance of efficient global standard processes.
About our future employee

You should speak English fluently and have a minimum of 2 years of experience in similar position (for senior role, a minimum of 5 years of experience is required).

Additionally, we are looking for:

  • Bachelor's Degree; preferably in engineering, sciences, pharmaceuticals or biotechnology or equivalent and longstanding professional experience in regulations and processes.
  • Knowledge and understanding of Computer Systems Validation regulation (CSV), including GAMP5, 21CFR Part 11, CSA framework and EU Annex 11, and Data Integrity regulation.
  • Demonstrated experience in SAP PM module.
  • Experience in EHS (SAP solutions) is valuable.
  • Good Knowledge of GxP (Good Practices) regulations within the Pharmaceutical Industry would be an advantage.
  • Experience with agile methods (e.g., SCRUM, Kanban) and tools (e.g., JIRA) would be an advantage.
  • Good analytical capabilities and problem-solving competence including a proper understanding of prioritization.
  • Dedicated team player with good communication skills, and a structured way of working.

As a Senior Process Specialist, you additionally have:

  • Profound knowledge and understanding of Computer Systems Validation regulation (CSV), including GAMP5, 21CFR Part 11, CSA framework and EU Annex 11, and Data Integrity regulation.
  • Several years of experience in SAP PM module.
  • Excellent presentation skills.

  • Vice President, Senior Model Development

    2 tygodni temu

    Wrocław, Województwo dolnośląskie, Polska BNY Pełny etat 60 000 zł - 120 000 zł rocznie

    Master's Degree/PhD in a quantitative discipline such as engineering, mathematics, physics, statistics, economics. The candidate must have a superb quantitative and analytical background with a solid theoretical foundation coupled with strong programming, documentation and communications skills. Minimum 3 years (5-10 preferred) of modeling related experience...

  • Regular+/Senior .NET Developer

    2 tygodni temu

    Wrocław, Województwo dolnośląskie, Polska Spyrosoft Pełny etat 40 000 zł - 60 000 zł rocznie

    Tech stack:.NET v10 and C#Domain-Driven Design (DDD)Microservices ArchitectureCQRS (Command Query Responsibility Segregation)SQLAzureAI Tooling: Proficiency with tools like GitHub Copilot to maximize productivity and code quality.Requirements:5+ years of commercial experience in software engineering.Excellent command of .NET 10.Strong experience with...

  • Azure Cloud Engineer

    1 tydzień temu

    Wrocław, Województwo dolnośląskie, Polska Luxoft Poland Pełny etat 60 000 zł - 120 000 zł rocznie

    Project Description:The Cloud Engineering and Automation team is part of the Corporate Technology division in the Bank Securities. This is a small team currently consisting of two Cloud Architects/Engineers, which will be overseen by the Head of Cloud Engineering and Grid Computing.The primary cloud platform is Azure, with limited support for Oracle Cloud....

  • Software Engineer, Ceph

    2 tygodni temu

    Wrocław, Województwo dolnośląskie, Polska Canonical - Jobs Pełny etat 40 000 zł - 80 000 zł rocznie

    Canonical is a leading provider of open source software and operating systems to the global enterprise and technology markets. Our platform, Ubuntu, is very widely used in breakthrough enterprise initiatives such as public cloud, data science, AI, engineering innovation, and IoT. Our customers include the world's leading public cloud and silicon providers,...

  • Information Security Engineer – Cyber Threat Detection

    3 dni temu

    Wrocław, Województwo dolnośląskie, Polska Ryanair - Europe's Favourite Airline Pełny etat

    DescriptionRyanair Labs are currently recruiting for a Information Security Engineer – Cyber Threat Detection & Response to join Europe's Largest Airline GroupThis is a very exciting time to join Ryanair as we look to expand our operation to 800 aircraft and 300 million guests within the next 10 years.Ryanair Labs is the technology brand of Ryanair. Labs...

  • Advanced Software Engineer

    2 tygodni temu

    Wrocław, Województwo dolnośląskie, Polska Relativity Pełny etat 146 000 zł - 218 000 zł

    Posting TypeRemoteJob OverviewRole summaryAs a Advanced Software Engineer, your primary mission will be to design, write, test, deploy, and support our Relativity cloud (Azure) software products in .NET/C#. You will work in a scrum team collaborating with other members of the engineering team and business stakeholders to support the development of products,...

  • Senior Data Architect

    4 dni temu

    Wrocław, dolnośląskie, Polska Experis Manpower Group Pełny etat 30 zł - 240 zł

    Experis to światowy lider rekrutacji specjalistów i kadry zarządzającej w kluczowych obszarach IT. Z nami znajdziesz konkurencyjne oferty zatrudnienia oraz ciekawe projekty IT skierowane zarówno do ekspertów z wieloletnim doświadczeniem, jak i osób, które dopiero zaczynają swoją przygodę w branży IT.Senior Data Architect (Hybrid – Wrocław, 2...

  • Vice President, Senior Model Development

    3 dni temu

    Wrocław, Województwo dolnośląskie, Polska BNY Pełny etat

    Job DescriptionTitle in the contract: Vice President, Model DevelopmentAt BNY, our culture allows us to run our company better and enables employees' growth and success. As a leading global financial services company at the heart of the global financial system, we influence nearly 20% of the world's investible assets. Every day, our teams harness...

  • Linux Devices Software Engineer

    2 tygodni temu

    Wrocław, Województwo dolnośląskie, Polska Canonical - Jobs Pełny etat 60 000 zł - 80 000 zł rocznie

    This role is one of our general tracks. Apply here for all engineering teams at Canonical who work on low-level system technology on autonomous devices across all seniority levels.We hire careful and conscientious engineers who appreciate the challenge of memory, performance, battery and connectivity constrained code that has to work every time in an...

  • Senior EMEA Commercial Excellence Data Analyst

    5 dni temu

    Wrocław, Województwo dolnośląskie, Polska BD Pełny etat

    Job Description SummaryThe Senior EMEA Commercial Excellence Data Analyst is a hands on, data driven role that supports both Sales Force Effectiveness (SFE) and Pricing functions within Commercial Excellence.This role will help enable and augment the work that both SFE and Pricing functions undertake within Biosciences EMEA Commercial Excellence.Job...