CSV Engineer
Job brief
This position requires the following requirements for employment at Stallergenes Greer and includes but not limited to:
- Execute pharmaceutical CSV project assignments including implementation of new systems, remediation of legacy, and re-validation of existing computerized systems
- Evaluate, and define technical needs and make recommendations
- Execute multiple CSV projects utilizing Project Management methodology
- Directly manage assigned projects to satisfy specific project/client needs
- Generation / execution of System Impact and Critical Aspect Assessment Impact
- Coordinate and interface with Validation Supervisor (CSV), as well as engineering and quality assurance groups to ensure successful project execution
- Lead cross-functional project teams in the development of validation deliverables
- 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 Requirements
This position requires the following minimum education:
- Bachelor’s Degree in Computer Sciences, Engineering or related field.
Work Experience Requirements
- Minimum of 5-8 years of experience in a highly regulated environment: pharmaceutical, biotechnology, medical devices or related industry
- 1 to 2 years of experience in project management (preferred)
- Strong knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation
- Familiar with off-the-shelf, configurable, and custom-developed applications
- Knowledge of validation deliverables associated with each step of the computer system life cycle
- Experience with various technologies and automated systems used in the pharmaceutical and medical devices industries
- Knowledge of Information Management, Business System (ERP), PLC or SCADA, DCS, Process Control, laboratory instrumentation, data archive/historian, Building Management Systems, etc.
- Experience in process automation an asset
- Experience in pharmaceutical/biotech and/or Medical Devices manufacturing an asset
Physical Demand(s)
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The position requires sitting and stand for long period of time on occasion.
- The position requires occasional travel.
Computer Skill(s)
- To perform this job successfully, an individual should have knowledge of Microsoft Office, quality systems’ software, calibration software, building management software and ERP systems.
Additional Skill(s)
- 1-2 years’ experience with ERP or EQMS Systems is desired.
- 3 years’ experience in Computer or Equipment Validation or Programmer role in the pharmaceutical and/or medical devices industries.
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
Share !
Join us !
Related searches :
Head of IT Security & Infrastructure
Position Summary
[...] See moreMycology Technician
Primary Responsibilities
[...] See more