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Ingénieur Procédés / Processes Engineer (Formulation, Filling, Cleaning), Vernouillet

Created 10/16/2021
Reference 743999779715455
Category Pharmaceuticals
Job type Full Time
Country France
City Vernouillet
Zip Not specified
Salary Competitive
Company Description

At LEO Pharma, we are at a pivotal point in our transformation journey to advancing medical dermatology by developing new biologics, in a mostly unexplored therapeutic area in the world today. Every day, we seek inspiration from people living with skin diseases. We are passionate about identifying and addressing their greatest health needs, to both advance medical dermatology and help them live fulfilling lives. As a purpose-driven company, high performance is measured equally as commercial results, brand performance and the positive impact we create - for health care professionals and their patients. These aspirations are encapsulated in our perpetual quest for the world's best talent.

Established on the national territory since 1958, LEO Pharma France, is today the first subsidiary of the LEO Group, with a turnover of about 500 M€. With over 600 employees (including 400 at the Vernouillet production site in Eure-etLoir and more than 220 at the Voisins-le-Bretonneux headquarters and on a Medical Visit), LEO Pharma France is a responsible player in terms of employment in France. Established in Vernouillet since 1964 on almost 7,500 m², the LEO Pharma production site in France is at the forefront of current technologies, thus meeting international standards for quality and safety. This site specializes in the manufacture of injectable preparations (pre-filled syringes) and dry forms. He is the pilot and flagship of the Group because he produces Innohep® (Low Molecular Weight Heparin) for the whole world and thus exports 70% of its production. The Vernouillet site continues to grow in terms of production capacity and employees. The site is also certified ISO 14001 and OHSAS 18001.

Job Description

Reporting directly to MSAT Senior Manager, and part of team of 9 experts, you will support the cleaning, formulation and filling processes at site Vernouillet ensuring implementation Document Name: LEO Pharma New req notification for Recruiter 20200608 Updated on: 15th of September, 2020 Created by: Karolina Molikiewicz, updated by: Martyna Kalinowska of requirement by preparing relevant operational and validation documents.

Your main responsibilities:

Exercising dedicated ownership of our thrombosis productand process requirements:

  • Support preparation of risk assessment for Innohep® cleaning, formulation and filling processes
  • Support maintenance and give input to procedures describing requirements for cleaning, formulation and filling processes
Securing high quality and compliant manufacturing processes by preparing and reviewing process related documents:

  • Support and provide input to cleaning, formulation and filling sections of site VMP and VMP for large projects
  • Prepare VMP for projects initiated by MSAT department
  • Prepare cleaning, formulation and filling validation documents for products and processes
  • Plan and perform tests during cleaning, formulation and filling validation and associated development cycle
  • Support review of cleaning, formulation and filling Innohep® Master Batch Record
  • Support and provide input to ongoing process verification for Innohep®
  • Support activities linked with sterilization and aseptic processes
Ensuring smooth implementation of new product & processes:

  • Writing CC cases (when relevant)
  • Support implementation of new requirements regarding cleaning, formulation and filling processes
Supporting site in solving critical quality and production issues, commenting of deviations involving processes which MSAT is responsible for. Lead deviation when it is relevant

Guarding our License-to-Operate

Propose and implement optimizations, improvements

Qualifications

Your profile:

  • Pharmacist, chemist, engineer or equivalent academic degree with at least 2-5 years of experience within pharma industry.
  • Experience from working with cleaning, formulation and filling processes.
  • Knowledge about EU GMP rules incl. guideline/annexes and experience from working in a GMP regulated environment.
  • Experienced with performing validation documentations.
  • A strong team player with good communication skills who can work with all stakeholder in the organization.
  • English skills in verbal and in writing, at a level which enables a good communication and collaboration with global organization and stakeholders

Additional Information

Please note that we review applications and conduct interviews on an ongoing basis.