Want to be part of a high performing team? We offer that
Ready to invest in your career? We offer that too
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, an innovative pipeline, 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 hiring for our site in Ludwigshafen/Rhine a highly motivated Validation Manager (all genders) to support our diverse team.
In this role you coordinate the development and maintenance of the company’s validation program in compliance with applicable regulatory and AbbVie requirements.
Managing, co-ordination, implementation and active participation in the site Validation Program you ensure team compliance to procedures, policies and guidelines ensuring adherence with cGMP and HPRA/FDA regulations and company policies, procedures, and guidelines as all times. You are responsible for presenting and taking ownership of own area during regulatory inspections and corporate audits.
This position is crucial in identifying systems requiring validation and ensuring that this activity is documented, actioned and resolved and supports Bulk Manufacturing, Packaging, Combination Products and Medical Devices and the site KPI’s.
Does this sound interesting to you?
Then let us tell you more on the role.
In this role you:
- Generate / maintain the Validation Master Plans, Project Validation Plans, Protocols and final reports to cGMP standard.
- Manage validation change control process.
- Act as site SME on all Validation issues and provides guidance on same.
- Support all manufacturing processes of existing and new products for Bulk, Packaging, Combination Products and Medical Devices including trouble shooting, documentation, deviations, statistical analysis, technical trials, process validation or compliance topics.
- Realize projects by achievements of defined goals within time and budget as well as alignment of local projects with global strategies and initiatives.
- Ph.D qualification in Science or Pharmacy, Pharmacist, Engineer (Master, Dipl Ing)
- At least 3 years experience in pharma environment, especially manufacturing
- Strong pharmaceutical knowledge
- Relevant experience in a cGMP environment, familiarity with the Regulatory and QA issues surrounding the manufacture
- Teamwork, stakeholder management, problem analysis & solving skills, driving the business for success & excellence
- Strong written and verbal communication skills in German
- Fluency in English is requirement in order to communicate with required colleagues globally
Are you ready now to be part of this innovative diverse team? Apply Now!
We are looking forward to your application. Please provide information about your salary expectations and possible start date in your motivation letter.
An equal opportunity employer. AbbVie welcomes and encourages diversity in our workforce.
Learn more about AbbVie Deutschland at www.abbvie.de. Visit www.abbvie-care.de for more information about the therapeutic areas in which we’re active.
Job Type: Experienced