Quality Engineer, CSV & Digital Systems

Job Description

Job DescriptionDetailsDescription: Title: Quality Engineer – CSV & Digital SystemsAssignment Duration: 6 months with possible extensionDavie, FLShift Details: Monday to Friday 8am – 5 pm (40 hours per week) Convert to Perm: Depending on opens 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).• 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 strategieso 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 5o 21 CFR Part 11 / Annex 11o Data Integrity (ALCOA+)• Practical experience with:o MES / EBR systemso 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 approacheso Commissioning & Qualification (C&Q) integration with CSV• Prior involvement in:o FDA inspections related to computerized systemso 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