Quality Engineer
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Job Location:
Monthly Salary:
Posted on:
15 hours ago
Vacancies:
1 Vacancy
Job Summary
Stefanini Group is hiring!
Stefanini is looking for Quality Engineer CSV & Digital Systems in Davie FL (Onsite)
For quick Apply please reach out to Ghanshyam Sharma - call:
/ email:
Work Hours:M-F (40 hours)
Work Location:Davie FL (Onsite)
Shift:1st Shift (8:00 AM - 5:00 PM)
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:
- MES / EBR 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.
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:
- 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.
Core Essential skill sets (Must Have):
- Recent Masters graduate Masters 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:
Required Technical Skills:
Strong working knowledge of:
- CSV lifecycle & GAMP 5
- 21 CFR Part 11 / Annex 11
- Data Integrity (ALCOA)
Practical experience with:
- MES / EBR systems.
- Process Historians (PI etc.)
- 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 :
- 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.
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.
Listed salary ranges may vary based on experience qualifications and local market. Also some positions may include bonuses or other incentives.
Stefanini takes pride in hiring top talent and developing relationships with our future employees. Our talent acquisition teams will never make an offer of employment without having a phone conversation with you. Those face-to-face conversations will involve a description of the job for which you have applied. We also speak with you about the process including interviews and job offers.
About Stefanini Group
The Stefanini Group is a global provider of offshore onshore and near shore outsourcing IT digital consulting systems integration application and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas Europe Africa and Asia and more than four hundred clients across a broad spectrum of markets including financial services manufacturing telecommunications chemical services technology public sector and utilities. Stefanini is a CMM level 5 IT consulting company with a global presence. We are CMM Level 5 company.
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#LI-ONSITE
Required Experience:
IC
Key Skills
- APQP
- Quality Assurance
- Six Sigma
- ISO 9001
- PPAP
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
