Validation Engineer (m/f)

Région
Liège (Ville) (BE)
Publication
jeudi 6 septembre 2018
Date limite
dimanche 21 octobre 2018
Réf
CDMO-VPE-092018
Type de contrat
CDI
Temps de travail
Temps plein

Validation Engineer (m/f)

Company

Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in women’s health, with a particular focus on fertility, contraception and menopause. Mithra’s goal is to develop new and improved products that meet women’s needs for better safety and convenience. Its two lead development candidates – a fifth generation oral contraceptive, Estelle®, and a next generation hormone therapy, Donesta®- are built on Mithra’s unique natural estrogen platform, E4 (Estetrol). Mithra also develops, manufactures and markets complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its Mithra CDMO.

Mithra was founded in 1999 as a spin-off of the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart. Mithra has an approximate headcount of 200 staff members and is headquartered in Liège, Belgium.

Description

Mithra Pharmaceuticals is looking for a Validation Engineer for its integrated technology platform (R&D/Production) based in Flémalle.

Duties and Responsibilities

  • Define the (continuous) validation strategy based upon the guideline and benchmarks for a specific value stream.
  • Executes tasks as required to implement this validation strategy and maintain in a validated state the cleaning processes and manufacturing processes to demonstrate that product will perform consistently as intended:
    • Manage the validation master plan for the value stream (e.g. sterile unit, solid dosage form unit, polymer unit, QC, IT…)
    • Communicate with the production team to have raw material/assemblies/resources for the validation.
    • Write the validation protocols
    • Train operators in SOP, work instructions and protocols, related to the validation.
    • Follow up the validation runs on the production floor.
    • Follow up the QC results for each run of validation.
    • Write the validation report.
    • Manage, write, investigate and follow up of all deviations related to the validation study.
    • Gain experience of the subject to become the validation expert, by working together closely with the production team.
    • Support the production team, when process failures or difficulties occur.
    • Act as an SME during inspections/audits

Profile

  • Master’s degree in a technical or business discipline: chemistry, physics, engineering, biochemistry, management
  • Minimum 3 years of operational experience, ideally in a pharmaceutical environment
  • Excellent communication skills (verbal & written)
  • Cross functional collaboration skills
  • Good knowledge of French and of English (spoken, written, read). Any other language is an asset
  • Hands on mentality
  • Strives in fast changing environment
  • Shows good understanding of GMP repository, with ability to translate to operational details
  • Flexible, able to set priorities and solution oriented
  • Good knowledge of Microsoft Office
  • Resistant to stress

What we offer

Varied and motivating responsibilities within a fast growing company
An attractive salary package in line with your experience

Applications

Send your CV and application letter via button POSTULER.
Your email must mention following subject: CDMO-VPE-092018

Recruitment Agencies, please refrain from contacting us or sending us CVs on a spontaneous basis

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