Sunrise Systems, Inc. ยท 1 month ago
Computer System Validation Engineer
Bothell, WA
Full-time
Hybrid
Mid, Senior Level
$73/hr - $75/hr
4+ years expSunrise Systems, Inc. is looking for a Computer System Validation Engineer to lead and execute validation activities for GxP electronic systems and applications. The role involves collaborating with various stakeholders to ensure compliance with relevant procedures and regulations throughout the validation lifecycle.
Information Technology & Services
Responsibilities
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
Qualification
Required
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 the development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts [IQ / OQ / PQ or equivalent], Summary Reports, Trace Matrices, SOPs, etc.)
Benefits
ACA compliant medical coverage
Dental insurance
Vision insurance
Sick time benefits as required per State regulations
Company
Sunrise Systems, Inc.
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry.
501-1000 employees
H1B Sponsorship
Sunrise Systems, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (2)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Ruchi Hajra
Senior Account Manager/Client Servicing/Talent Acquisition Partner
Company data provided by crunchbase