What are the responsibilities and job description for the CSV Technician position at Stallergenes Greer?
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
Job Type: Full-time
Pay: Up to $60,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Education:
- Associate (Preferred)
Experience:
- CSV: 2 years (Preferred)
Ability to Commute:
- Lenoir, NC 28645 (Preferred)
Ability to Relocate:
- Lenoir, NC 28645: Relocate before starting work (Preferred)
Work Location: In person
Salary : $60,000
