4 days ago

Validation Engineer

Glenmark Pharmaceuticals S.A.

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Glenmark Pharmaceuticals (www.glenmarkpharma.com) is a research-led, global, fully integrated pharmaceutical company. The group is present in more than 40 countries including the USA and Europe. Our Swiss operation encompasses the Company’s Biological Research and Development Centre located in the Canton of Neuchâtel and focuses on the discovery and development of novel biological entities comprising monoclonal antibodies and proprietary bispecific format. We provide an attractive, international and multicultural research environment with career opportunities for scientists engaged in applied biomedical sciences. Located in a beautiful area of Switzerland, we are a rapidly growing company with an attractive and competitive early research and development portfolio in the areas of immuno-oncology, respiratory and dermatology research.

Validation Engineer

Glenmark Pharmaceuticals www.glenmarkpharma.com is a research-led global fully integrated pharmaceutical company. The group is present in more than 40 countries including the USA and Europe. Our Swiss operation encompasses the Company's Biological Research and Development Centre located in the Canton of Neuchâtel and focuses on the discovery and development of novel biological entities comprising monoclonal antibodies and proprietary bispecific format. We provide an attractive international and multicultural research environment with career opportunities for scientists engaged in applied biomedical sciences. Located in a beautiful area of Switzerland we are a rapidly growing company with an attractive and competitive early research and development portfolio in the areas of immuno-oncology respiratory and dermatology research. Validation Engineer RESPONSIBILITIES

The Validation Engineer is responsible for coordinating and executing validation activities related to biopharmaceutical facilities utilities equipment and associated systems e.g. HVAC automation . This position drives validation activities from initiation to successful completion as the primary decision maker for assigned validation responsibilities including deviation investigations and risk/impact assessments. This role closely interacts with Manufacturing Sciences and Technology Site Engineering and Quality Assurance.


Prepare and execute validation protocols involving facility equipment utilities and associated automation CSV
Prepare review and approve SOPs validation deviations change control validation summary reports and associated documentation
Coordinate validation activities with internal departments external contractors and suppliers
Prepare and deliver cross-functional training in validation methodologies protocols and related procedures to facilitate validation activities
Primary point of contact for validation-related issues arising during validation activities including protocol execution
Investigate deviations/non-conformances to determine potential impact on product quality validation status and associated compliance requirements
Provide support to commissioning activities including review of commissioning plans procedures etc.
Represent validation as a subject matter expert SME in all project phases including commissioning and qualification execution
Manage all communication contracts and appropriate technical follow up with relevant suppliers with respect to validation activities
Participate in on-call alarm system management with occasional onsite presence required outside of regular working hours
Perform other relevant responsibilities as required



REQUIREMENTS


Bachelor of Science BSc or Masters of Science MSc in engineering or relevant scientific discipline
5+ years of experience in a Validation/Quality role in a biopharmaceutical manufacturing environment
Demonstrated knowledge of GMP and GEP ISPE PICS ICH
Fluent French spoken and written
Proficiency in business-level English with ability to write reports in English
Advanced Microsoft Office skills Project Management and Visual Basic are a plus
Strong sense of discipline exceptional organization skills excellent team orientation and hands-on approach to work
Ability to work independently with proven experience in problem analysis/solving anticipation and proactivity

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