Cynet Systems · 2 days ago
Quality Engineer – CSV And Digital Systems
Davie, FL
Full-time
Onsite
Mid Level
3+ years expCynet Systems is a company focused on ensuring compliance and validation in regulated manufacturing environments. The Quality Engineer – CSV & Digital Systems will oversee the Computer System Validation lifecycle and collaborate cross-functionally to ensure project execution aligns with regulatory standards.
Human ResourcesEmploymentRecruitingStaffing Agency
Responsibilities
Review and approve CSV lifecycle documents including VMP, URS, FRS, HDS, Risk Assessments, IQ, OQ, PQ, RTM, and Summary Reports
Ensure risk-based validation approaches align with GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+ principles
Evaluate system changes through change control processes and assess GxP impact and validation requirements
Support periodic reviews and revalidation activities for existing systems
Act as Quality reviewer and approver for MES and EBR platforms
Review and approve historians such as OSIsoft PI or equivalent systems
Provide oversight for advanced analytics tools used for GxP trending
Review and approve laboratory systems including Empower and similar platforms
Evaluate configurations related to data acquisition, timestamping, audit trails, access control, and electronic records and signatures
Ensure proper segregation between GxP and non-GxP analytics use cases
Assess and approve data flows, interfaces, and system integrations
Support regulatory inspections and internal audits related to computerized systems
Partner with Engineering, Automation, MS&T, IT, and Operations teams to enable compliant validation strategies
Provide Quality input during project design, FAT, SAT, commissioning, and implementation phases
Balance risk-based validation to avoid over-validation while maintaining compliance and inspection readiness
Qualification
Required
Master's degree in Engineering, Computer Science, Life Sciences, or related field
3 to 5 years of experience in pharmaceutical or regulated manufacturing environments
Minimum of 2 years of experience within a Quality organization
3 or more years of hands-on CSV experience reviewing and approving validation documentation
Direct experience supporting manufacturing or utilities systems
Strong knowledge of CSV lifecycle and GAMP 5
Strong knowledge of 21 CFR Part 11 and Annex 11 requirements
Strong understanding of Data Integrity principles including ALCOA+
Practical experience with MES and EBR systems
Experience with process historians such as PI systems
Experience with advanced analytics platforms in a GxP environment
Ability to evaluate risk-based validation approaches for dashboards, reports, and models
Familiarity with change control, deviation management, and CAPA systems
Preferred
Experience with Werum Client-X, Seeq, PI Vision, or Power BI for regulated trending
Experience with agile or lean validation approaches
Experience integrating Commissioning and Qualification activities with CSV
Prior involvement in regulatory inspections related to computerized systems
Experience supporting digital transformation or Industry 4.0 initiatives
Company
Cynet Systems
Headquartered in Washington DC Metro Area, Cynet Systems is a top talent supplier for companies across North America.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Ashwani (Ash) M.
Partner and Co-CEO
Nikhil "Nick" Budhiraja
Founder / Co-CEO
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