Quality System Validation Engineer — GxP Compliance

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

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.