Job Description
Job Description
Title: Quality Engineer – CSV & Digital Systems
Location: Davie, FL 33314
Duration: 6 months (temp to perm possible)
Pay: $36.61 /hr. on w2
Monday to Friday 8am – 5 pm (40 hours per week)
Job Description:
Core Essential skill sets (must have):
• Recent Master’s graduate master’s degree in engineering, Computer Science, Life Sciences, or related field.
• Min 3 years’ experience in pharmaceutical or regulated manufacturing; out of which 2 years in quality organization
• Min 3 years hands-on CSV experience reviewing and approving validation documentation.
• Direct experience supporting manufacturing or utilities systems (not just lab systems).
• Medical screening requirements:
Key Responsibilities:
Computer System Validation (CSV)
• Review and approve CSV lifecycle documents (VMP, URS, FRS, HDS, Risk Assessments, IQ/OQ/PQ, RTM, Summary Reports).
• Ensure risk-based validation approaches aligned with GAMP 5, 21 CFR Part 11, and Data Integrity (ALCOA+) principles.
• Evaluate system changes through change control, assessing GxP impact and validation requirements.
• Support periodic reviews and re-validation activities for existing systems.
Digital Systems & Platforms
• Act as Quality reviewer/approver for systems including:
o MES / EBR platforms (e.g., Werum PAS-X or similar)
o Historians (OSIsoft PI or equivalent)
o Advanced analytics tools (Seeq, used for GxP trending)
o Empower and other lab systems
• Review configurations related to data acquisition, time stamping, audit trails, access control, and electronic records/signatures.
• Ensure proper segregation between GxP vs non-GxP analytics use cases.
Data Integrity & Compliance:
• Assess and approve data flows, interfaces, and integrations between systems.
• Support regulatory inspections (FDA, EMA) and internal audits related to computerized systems.
Cross-Functional Collaboration
• Partner with Engineering, Automation, MS&T, IT, and Operations to:
o Enable faster project execution with compliant validation strategies
o Avoid over-validation while maintaining inspection readiness
• Provide Quality input during project design, FAT/SAT, and commissioning phases.
Required Qualifications:
Education:
• Master's degree in Engineering, Computer Science, Life Sciences, or related field.
Experience:
• 3-5 years experience in pharmaceutical or regulated manufacturing; out of which 2 years in quality organization
• 3+ years hands-on CSV experience reviewing and approving validation documentation.
• Direct experience supporting manufacturing or utilities systems (not just lab systems).
Company DescriptionSelect Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differenti
Editing this field will affect all jobs at this hiring company
Who should get alert emails for new candidates?ators to comprehensively support your diverse workforce needs.
Based in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities
Company Description
Select Source International (SSI) is a distinguished staffing company with nearly 25 years of experience, renowned for delivering top-tier workforce solutions encompassing staffing, recruiting, and managed services. As a proud supplier, we bring a wealth of expertise and best-in-business differenti\r\nEditing this field will affect all jobs at this hiring company\r\n\r\nWho should get alert emails for new candidates?ators to comprehensively support your diverse workforce needs.\r\n\r\nBased in Minneapolis, Minnesota, USA, SSI has established itself as a global leader, serving a broad clientele across industries with unwavering dedication and excellence. SSI is ISO 9001, 14001, and Soc2 Type2 certified, underscoring our commitment to quality and security. We have garnered numerous sustainability and supplier diversity awards, further validating our industry-leading capabilities