Validation Specialist

工作内容

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Welcome to AbbVie!

At AbbVie, we offer you the resources and a global reach to empower your innovative mindset. From day one, we’ve known it takes teamwork and collaboration to develop the scientific breakthroughs, innovative pipelines, and therapies that change millions of patients’ lives around the world. In short, we know it takes “you” to make those ground-breaking advancements happen. We take pride in serving and supporting our communities and protecting the environment, making a lasting impact that’s felt within healthcare and beyond.

We are now recruiting a Validation specialist to join our Engineering team in AbbVie Liège - Odyssea Pharma in Liège.

Odyssea Pharma is a pharmaceutical production site based in Liège, Belgium, part of the former Allergan Group, now included in Abbvie.Our success is based on the commitment of our teams on the site and around the world.

Odyssea Pharma sprl is one of the Abbvie’s centers of excellence for women’s health, offering the GMP manufacturing of the Levosert ™ hormonal intrauterine device and a quality and regulatory expertise from a dedicated site located in Liège (Grace-Hollogne), in Belgium.

The company has successfully developed the Levosert ™ (levonorgestrel-releasing intrauterine device) and today launches the mass production of the hormonal IUD with almost unique equipment for the global market.

In this role, you will be presented with exciting and challenging opportunities to work on multiple projects, ranging from manufacturing support activities to late-stage processes improvements, scale-up, new product introductions and technology transfers. You will be the site subject matter expert for the entire validation and qualification processes.

As part of the high performing technical operations team, you will optimize troubleshoot and develop processes to ensure the highest quality product is manufactured at our IUD facility. While your primary focus will be supporting the IUD facility, you will have the potential opportunity to build your drug product process knowledge as part of the team. You will be in charge of setting up a robust industrialization process to enable us to move to efficient production. The position reports to the Head of engineering.

Description:

Day to day,

• Leadership of all commissioning and validation activities during project lifecycle
• Process and equipment optimization in order to sustain and improve product quality, yields and throughput. Making recommendations and implementing measures to improve production systems, equipment performance, yields and quality of product.
• Run the annual validation plan, build the validation strategy, review procedures and train people
• Execution of process development on existing products.
• Initiating design of new - or modified process equipment and driving (re-) qualification of equipment, (re-) validation.
• Providing technical expertise & leadership for the investigations and resolution of process deviations in large scale processes through effective root cause analysis, Impact assessment, CAPA definition (& execution) and design of (pilot / scale down) studies. The role includes authoring change controls for new process introduction or to assess technical modifications.
  
  

Key Areas of Responsibility:

• Preferable at least 8 years’ experience in process engineering with strong technical depth will be considered, especially in validation project management
• Proven experience of equipment qualification / validation, from URS creation and qualification execution to the decomissionning of the asset (End-2-End V-cycle lifecyle)
• Relevant experience in validation of batches processing, automation, CSV, technical matters in a cGMP pharmaceutical industry.
• Demonstrated project management skills, including the ability to deliver projects on schedule, within budget, and meeting the predefined quality requirements are required.
• Practical experience with optimization of processes.
• Track record of defining / leading / coordinating specific projects.
• Continuous improvement mindset and experience with lean manufacturing methodologies.
• Excellent oral & writing skills, both in French & English, to author and approve comprehensive and accurate technology and manufacturing documentation, procedures, specifications and protocols/reports.
• Ability to compile, analyze and summarize large amounts of information and complex situations into a comprehensive but concise document that efficiently supports decision making processes.