QA Engineer Validation Project

QA Engineer validation project (M/F) - based in Chartres

**Category**:Quality**Location**:Boulogne-Billancourt, Île-de-France, FR- Are you passionate about the pharmaceutical industry? Do you want to contribute to a global program involving multiple sites worldwide? Would you like to be part of a rapidly expanding company? If so, you might be the person we're looking for- Our opportunity is based at the Chartres production site, which is undergoing a massive investment of 2.1 billion euros as part of a global program involving other sites worldwide.**The position**
- As a Quality Assurance Engineer Validation Project, you will play a crucial role in ensuring the successful start-up of future production lines and associated equipment within specified timelines, adhering to Good Manufacturing Practices (GMP) and internal procedures.- You will have a cross-functional position, collaborating with various project departments such as aseptic production, finished product production, building and utilities, IT, warehouse and logistics, and quality control.- As an Engineer in Quality Assurance Project, your responsibilities will include:
- Participation in different project stages, including defining user requirements, supplier selection and evaluation, equipment design validation, analysis of quality and regulatory risks, monitoring verification activities (FAT/SAT/IV/OV/PfV), and process validation.
- Establishing and challenging qualification and validation strategies.
- Building an effective communication network with central Quality Assurance and process teams (in Denmark), ensuring standardization of approaches and harmonizing work methods with other Novo Nordisk project entities worldwide (US, China, Brazil, Europe).
- Maintaining the validated status of equipment/processes.
- Preparing and ensuring the ramp-up (operational readiness) for Quality Assurance teams to guarantee a successful handover to operational teams.
- In this role, you'll have the exciting opportunity to work on cutting-edge technologies, including:
- AGV (Automated Guided Vehicles): Implementing advanced automated vehicles for efficient material handling.
- Warehouse Automation: Utilizing state-of-the-art technologies for warehouse automation.
- Isolator Filling with Ready-to-Use and Ready-to-Sterilize: Working on innovative filling processes under isolator conditions with ready-to-use and ready-to-sterilize solutions.
- Environmental Cleaning Program with Robots: Contributing to environmental cleanliness through advanced cleaning programs involving robotic technologies.

**Qualifications**:

- You have an engineering degree (BAC +5) or equivalent experience of at least 3-4 years in the pharmaceutical industry, specifically in the field of validation.
- You have experience in the qualification and validation of equipment such as washers, autoclaves, filling lines under isolators, assembly and packaging, etc.
- You have strong communication and persuasion skills, particularly in English in an international environment.
- You enjoy working in a multicultural team (occasional travel may be required).

**About The Department**
- As part of the “Fill and Finish Expansions” project, you will be connected to the Quality Assurance entity managing Novo Nordisk's entire investment project portfolio. You will play a key role in the extension project at the Chartres site, aiming to double production capacity by 2028-2030 to provide innovative treatments to an increasing number of patients.**Working at Novo Nordisk**
- Anchored in the region for more than 60 years, our Novo Nordisk production site in Chartres specializes in the production of insulin cartridges and vials, as well as the assembly and packaging of pre-filled pens.- Every day, more than eight million people around the world benefit from insulin produced in Chartres. Since 2021, the new building extension has been producing the latest generation of insulin injection devices.- As a major player in the Made in France sector, we actively contribute to the attractiveness of the territory through the implementation of the latest technologies and a proactive training policy.- We place the ecological transition at the heart of our concerns: we are committed to eliminating our environmental impact by 2030.-
**What’s In It For You**
- Joining Novo Nordisk means an exciting saving lives job, but also:
- An international culture where the well-being and development of our employees is at the heart of our priorities
- An attractive remuneration policy: profit-sharing, company savings plan, annual salary increases, stock options, etc.
- CSE benefits (culture vouchers, vacation vouchers, Christmas gifts, etc.)
- 65% health insurance cover, offering an excellent level of reimbursement
- Your public transport pass is reimbursed at 50%.
- Thoughtful touches to enjoy:
- Seasonal fruit and complimentary hot drinks
- Unbeatable company restaurant (fixed-price meal for less than €4), open from breakf