Quality Engineer – CSV & Digital Systems

SGS Consulting; Princeton (NJ); On-site; Full time

Job summary

A leading engineering consulting firm in New Jersey is seeking a Quality Engineer to oversee Computer System Validation (CSV) and Digital Systems. Key responsibilities include reviewing CSV documents, ensuring compliance with regulations, and collaborating with cross-functional teams. The ideal candidate will hold a master's degree in a relevant field paired with 3-5 years of experience in regulated manufacturing and strong skills in CSV lifecycle management and data integrity. This role offers a contract duration of 6 months with potential for extension and conversion to permanent.

Qualifications

• Recent Master's graduate master’s degree in relevant field.
• 3-5 years’ experience in pharmaceutical or regulated manufacturing.
• Direct experience supporting manufacturing or utilities systems.

Responsibilities

• Review and approve CSV lifecycle documents.
• Support regulatory inspections and internal audits.
• Partner with cross-functional teams to enable project execution.

Skills

Computer System Validation (CSV)

GxP knowledge

Collaboration skills

Data Integrity (ALCOA+)

Education

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

Tools

MES / EBR systems

Advanced analytics platforms (Seeq)

Power BI

Job description

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

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:
• 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.

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
• 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
• 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