CSV Technician
Job brief
Job Responsibilities:
This position requires the following requirements for employment at Stallergenes Greer and includes but not limited to:
- Core responsibilities include engaging end user for the purpose of source documentation (URS/FRS) generation, development of test scripts, installation, operational and performance qualifications, and system configuration and failure resolution.
- Execute pharmaceutical CSV validation project assignments including implementation of new systems, remediation of legacy, and re-validation of existing computerized systems
- Support multiple CSV projects following Project Management methodology
- Support generation / execution of System Impact and Critical Aspect Assessment Impact
- Support in the coordination and interface with Validation Supervisor (CSV), as well as engineering and quality assurance groups to ensure successful project execution
- Review and approve validation project documentation
- Develop validation deliverables including master plans, protocols and summary reports, as required
- Support development of best practices within the validation group, based on current industry practices and guidelines
Requirements
Education and Work Experience Requirements:
- Practical problem-solving skills.
- Team oriented.
- Good communication skills.
- Creative & proactive.
- Experience with software validation testing an asset.
- Familiar with process automation an asset
- Familiar with pharmaceutical/biotech and/or Medical Devices manufacturing an asset
- Associates degree in technical field or 2 years of computerized systems experience .
Additional Skills Required:
Computer Skill(s)
To perform this job successfully, an individual should have knowledge of Microsoft Office suite, quality systems’ software, calibration software, building management software and ERP systems
About STALLERGENES GREER Ltd
Stallergenes Greer is an international biopharmaceutical company specialized in the diagnosis and treatment of allergies through the development and marketing of Allergenic Immunotherapy treatments.
Our mission is to offer the full potential of precision medicine to improve the quality of life of people suffering from allergies.
Allergenic Immunotherapy (AIT) is the only treatment for respiratory allergic diseases that allows for a lasting re-education of the patient’s immune system by inducing an increasing tolerance to allergens.
With more than 1,100 employees worldwide, and production sites in Europe and the United States, Stallergenes Greer offers its medicines in 40 countries.
Would you like to participate in the development of a world expert group in its field, in a dynamic and multicultural environment ? Join our Stallergenes Greer teams !
- Job category : Other
- Job type : Full time
- Contract type : Permanent contract (CDI)
- Job location : United States
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