Quality Engineer – CSV & Digital Systems

Key Responsibilities:

Computer System Validation (CSV):

• Review and approve CSV lifecycle documents (VMP, URS, Client, 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 Client-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.

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:
• 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:

• Experience with:
  • Werum Client-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.

Medical Screening Requirements:

• Basic Bkg.
• 11 Panel drug + Fentanyl.
• Vision Screen - Near, Far, Color, Depth and Peripheral.
• Spirometry & OSHA Respirator Questionnaire.

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.