What are the responsibilities and job description for the Computer System Validation (CSV) Engineer position at Integrated Resources, Inc ( IRI )?
Job Title: Computer System Validation (CSV) Engineer
Location: Bothell, WA - Hybrid
Duration: 12 Months (Possible Ext)
Pay Range: $70 - $75/Hr. on W2
Job Description:
Location: Bothell, WA - Hybrid
Duration: 12 Months (Possible Ext)
Pay Range: $70 - $75/Hr. on W2
Job Description:
- The Computer Systems Validation (CSV) Contractor works cross-functionally to lead and execute validation activities for GxP electronic systems and applications.
- The partner with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle.
- His primary responsibility to ensure that routine tasks supporting validation of electronic systems and applications are documented in accordance with the relevant Client procedures and regulations.
- This includes coordination of system validation periodic reviews and audit activities as well as support of computer system validation efforts for new system implementations and changes to existing systems.
- Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements.
- Author, review and/or approve applicable CSV documentation
- Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures
- Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations
- Support health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities (as required)
- Strong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).
- Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)
- Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.
- Strong knowledge on MES systems (i.e. Emerson Syncade) and ERP systems (i.e. SAP or Oracle).
- Familiar with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)
- Ability to effectively communicate with both technical and non-technical team members.
- Strong interpersonal skills, especially regarding team work, client focus, verbal and written communication
- Knowledge of industry standard Quality and Compliance methodology to ensure our IT systems deliver the intended performance and ensure they meet regulatory requirements.
- Knowledge of cGMP, GXP, GAMP, including 21CFR part 11, and good documentation practices.
- Knowledge of IT service management platforms to support change IT operational events (i.e. ServiceNow).
- Knowledge and exposure to Business Quality Management Systems (i.e. Veeva).
- Strong technical and problem-solving skills and the ability to work independently. Demonstrated success working in a high-performing, business results-driven environment.
- Bachelor's degree in a life sciences, engineering, or technology discipline or a minimum of 5 years of equivalent biotechnology or pharmaceutical industry experience.
- Must have experience with Computer system validation of MES.
- Working knowledge of regulatory requirements and how they relate to existing and new business systems and practices, primarily GxP.
Salary : $70 - $75
