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Aseptic Operations Expert (m/f/d)
Work Your Magic with us!
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
As a Aseptic Operations Expert your scope concerns all activities, from formulation to filling and capping of containers, including equipment preparation activities.
You are responsible for identifying, assessing, and controlling the risks of contamination that may occur in the framework of aseptic production activities (drafting and updating of Contamination Control Strategy according to Annex 1 requirements, issue of Risk Assessments, smoke studies, relevant studies protocols/reports).
In this context, you also manage the validation activities of the aseptic process (APS) by means of:
definition of Aseptic Process Simulation (APS) strategy for the aseptic filling suites of the site;
drafting of documentation related to APS (Protocols, Risk Assessments, Reports, Plan);
coordination/organization of all activities related to the execution of the APS exercise;
on the floor supervision of activities.
Who you are:
Education in biotechnology, or equivalent
Mastery of the pharmaceutical environment and in particular of aseptic filling processes and aseptic practices (3-6 years experience)
Knowledge of Good Manufacturing Practices (BPF / GMP), in depth knowledge of Annex 1 EU GMP
Editorial quality (Procedures, risk analyses, deviations, etc.)
Team spirit, leadership, autonomy, proactivity, and good communication are qualities necessary for success
French mother tongue/fluent – Good level of English (minimum B2)
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of our diverse team!
US Equal Employment Opportunities
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.
We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.
North America Disclosure
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