Quality System Validation Engineer --MEHDC5741774

Compunnel Inc.; Town of Florida (NY); On-site; USD 80,000 - 120,000; Full time

Job summary

A pharmaceutical services company is seeking a qualified candidate for a role focused on reviewing and approving validation lifecycle documents, ensuring compliance with essential regulations. The applicant should have a master's degree and experience in pharmaceutical manufacturing, with hands-on validation experience. The position entails supporting FDA inspections, collaborating with various teams, and applying a risk-based approach to validation. This role offers an opportunity to contribute significantly to quality assurance processes within the industry.

Qualifications

• 3–5 years in pharmaceutical or regulated manufacturing.
• Minimum 2 years within a Quality organization.
• 3+ years hands-on Computer System Validation experience.
• Direct support of manufacturing or utilities systems.

Responsibilities

• Review and approve validation lifecycle documents including VMP, URS, FRS, HDS.
• Ensure compliance with GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+ Data Integrity principles.
• Assure proper segregation of GxP and non-GxP analytics.
• Support FDA and regulatory inspections.

Skills

CSV lifecycle & GAMP 5

21 CFR Part 11 / Annex 11

Data Integrity (ALCOA+)

MES / EBR systems

Process Historians (PI or similar)

Seeq or advanced analytics in GxP

Change Control

Deviations

CAPA

Risk‑based validation approach

Education

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

Job description

Responsibilities

• Review and approve validation lifecycle documents including VMP, URS, FRS, HDS, Risk Assessments, IQ/OQ/PQ, RTM, and Summary Reports
• Ensure compliance with GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+ Data Integrity principles
• Assess change controls and evaluate GxP impact
• Act as Quality reviewer/approver for:
• MES / EBR systems (e.g., Werum PAS-X or similar)
• Process Historians (OSIsoft PI or equivalent)
• Advanced analytics tools (Seeq – GxP context)
• Ensure proper segregation of GxP and non-GxP analytics
• Support FDA and regulatory inspections
• Partner with Engineering, Automation, IT, MS&T, and Operations
• Provide Quality input during FAT/SAT and commissioning phases

Required Qualifications

• Master’s degree in Engineering, Computer Science, Life Sciences, or related field
• 3–5 years in pharmaceutical or regulated manufacturing
• Minimum 2 years within a Quality organization
• 3+ years hands‑on Computer System Validation experience
• Direct support of manufacturing or utilities systems

Required Technical Skills

• CSV lifecycle & GAMP 5
• 21 CFR Part 11 / Annex 11
• Data Integrity (ALCOA+)
• MES / EBR systems
• Process Historians (PI or similar)
• Seeq or advanced analytics in GxP
• Change Control, Deviations, CAPA
• Risk‑based validation approach

Preferred Experience

• PI Vision
• Power BI (regulated trending)
• FDA inspection support
• Industry 4.0 / Digital transformation initiatives