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Quality Validation Expert
A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
You will be responsible for the guidance and direction of validation projects covering all the Life Science sites. You will provide expert guidance in documents as well as in direct interaction with individuals requesting guidance. In this role you will assist individuals on a site level as well as write guidance documents on a Life Science scope. You will provide expert guidance on all aspects of validation and will need to travel to directly assist individuals/site requiring specific support for a limited time during regulatory inspections and/or large projects. You will review and become an expert in the regulatory guidelines as well as being current on potential changes which may impact the validation requirements. You will also provide expert guidance during regulatory audits and will provide project management support for projects which don't have site specific support systems in place.
Who You Are:
- Bachelor’s degree in chemical or process engineering or another life science discipline
- 7+ years of experience in either a medical device manufacturing or API manufacturing or life science manufacturing
- 7+years of validations experience including but not limited to facility, manufacturing/packing equipment, process, cleaning, analytical testing, software validation
- 7+ years of experience in handling multiple projects
- 7+ years of experience in quality assurance
- Good written and verbal skills in English.
- Excellent computer skills, i.e., Word, Excel
- Experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processes
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.