Quality Engineer - CSV & Digital Systems (SK9758)
Job Description
Job Description
Pay: $31.61 - $36.61 per hour
Contract: 6 Months (Renewable)
Job ID: 9758
Location: Davie, FL
Client: Multinational Pharmaceutical
Job Title: Quality Engineer – CSV & Digital Systems
Shift Details: Monday to Friday 8am – 5 pm (40 hours per week)
Assignment Duration: 6 months with possible extension, depending on budget and performance
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).
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).
________________________________________
Required Technical Skills
- Strong working knowledge of:
o CSV lifecycle & GAMP 5
o 21 CFR Part 11 / Annex 11
o Data Integrity (ALCOA+)
- Practical experience with:
o MES / EBR systems
o Process Historians (PI, etc.)
o 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.
________________________________________
Preferred / Nice-to-Have
- Experience with:
o Werum PAS-X, Seeq, PI Vision, Power BI (for regulated trending)
o Agile or lean validation approaches
o Commissioning & Qualification (C&Q) integration with CSV
- Prior involvement in:
o FDA inspections related to computerized systems
o Site digitalization or Industry 4.0 initiatives
________________________________________
Key Competencies
- 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
Job Type: Contract
Benefits:
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person
Company Descriptionwww.techdataservice.com