What are the responsibilities and job description for the Analytical Validation Engineer position at AllSTEM Connections?
AllSTEM Connections is seeking an Analytical Validation Engineer to work onsite in E. Syracuse, NY.
This is a 12-month contract position. Possible extension/temp-to-hire.
Hourly rate is up to $57/hour.
M-F, 8AM - 5PM.
SUMMARY:
This position is responsible for preparing computer system validation documents to compliance with local and global regulatory requirements, and internal company standards. Ensure IT personnel complete QMS actions and routine system compliance activities are completed on time
RESPONSIBILITIES:
- Develop Computerized Laboratory Instrument Validation and Qualification documentation including:
- Validation Plans
- User and Functional Requirement Specifications (URS/FRS)
- Risk Assessments
- Configurations Specifications
- Design Detailed Design Specifications
- Installation and Operational Qualification Protocols (IQ/OQ)
- Performance Qualification (PQ) Protocols
- Traceability Matrices
- Validation Summary Reports.
QUALIFICATIONS:
- Direct experience or close familiarity with computer system qualifications is desired.
- Individual must have applied knowledge and understanding of regulatory requirements for lifecycle management of analytical instrumentation and computer system validation, including cGMP, 21 CFR Part 11 and Data Integrity.
- Strong project management, communication, and technical writing skills are required.
- The Analytical Validation Engineer will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management.
- Ability to take initiative, prioritize objectives for multiple projects, and adhere to scheduled timelines while maintaining flexibility.
- Ability to contribute to a team based, collaborative and positive environment, with clarity of purpose and high commitment to business goals is essential.
Salary : $57
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