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Computer Systems Validation Engineer
$77 - $77 / hour
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Overview
Job Description
- 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
- Other related duties as assigned
- Required Competencies: Knowledge, Skills, and Abilities:
- 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 cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, and good documentation practices.
- Knowledge of pharmaceutical, manufacturing and laboratory systems and equipment that support Biologics and clinical manufacturing.
- Knowledge of IT service management platforms to support incident, problem and 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.
- Understanding of computer system validation.
- Familiarity with MES systems (i.e. Emerson Syncade), ERP systems (i.e. SAP or Oracle) and EBRs (i.e. InfoBatch).
- Understanding of computer system validation (CSV).
- Bachelor's degree in a life sciences or engineering / IT discipline or equivalent industry experience (a combination of industry-specific education and work experience may be used to substitute this degree requirement) 4+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures
- Strong knowledge on Manufacturing Execution System (MES) validation.
- Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records / signatures
- Strong knowledge on development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)
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