Quality Engineer – CSV & Digital Systems

Quality Engineer – CSV & Digital Systems

Location:

Davie, FL

Job Duration: 6 months Contract

Shift: Monday to Friday 8am – 5 pm (40 hours per week)

Assignment Duration: 6 months with possible extension

Convert to Perm:
Depending on openings and performance

• 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).

• 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.

• Act as Quality reviewer/approver for systems including:
• MES / E  platforms (e.g., Werum PAS‑X or similar)
• Historians (OSIsoft PI or equivalent)
• Advanced analytics tools (Seeq, used for GxP trending)
• 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.

• Assess and approve data flows, interfaces, and integrations between systems.
• Support regulatory inspections (FDA, EMA) and internal audits related to computerized systems.

• Partner with Engineering, Automation, MS&T, IT, and Operations to:
• Enable faster project execution with compliant validation strategies.
• Avoid over‑validation while maintaining inspection readiness.
• Provide Quality input during project design, FAT/SAT, and commissioning phases.

• Master's degree in Engineering, Computer Science, Life Sciences, or related field.

• 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).

• CSV lifecycle & GAMP 5
• 21 CFR Part 11 / Annex 11
• Data Integrity (ALCOA+)

• MES / E  systems
• Advanced analytics platforms (Seeq) in a GxP context
• Ability to evaluate risk‑based validation for dashboards, reports, and models.
• Familiarity with change control, deviations, and CAPA systems.

• Werum PAS‑X, Seeq, PI Vision, Power BI (for regulated trending)
• Agile or lean validation approaches
• Commissioning & Qualification (C&Q) integration with CSV
• Prior involvement in FDA inspections related to computerized systems
• Site digitalization or Industry 4.0 initiatives
• Risk‑based decision making with quality and compliance focus
• Strong documentation review and technical writing skills
• Ability to challenge constructively while remaining solution‑oriented
• Comfortable working at the intersection of Quality, Engineering, and IT
• Pragmatic mindset: compliant and business‑enabling