Validation Engineer (m/f)
Validation Engineer (m/f)
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.
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
- 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
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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