QC - Validation Engineer

Roles & Responsibilities

We are looking for a QC Engineer to support validation of analytical laboratory instruments and computerized systems in a GMP-regulated environment. The role focuses on ensuring compliance with 21 CFR Part 11, Annex 11, ALCOA+ principles, and data integrity requirements.

Key Responsibilities

• Plan, execute, and document qualification / validation of analytical instruments (e.g., HPLC, GC, UV, CDS, LIMS, Empower).
• Prepare, review, and execute CSV deliverables such as URS, IQ / OQ / PQ, RTM, and summary reports.
• Perform data integrity assessments and ensure compliance with ALCOA+, GDP, and cGMP guidelines.
• Draft, review, and maintain validation-related SOPs for QC systems and equipment.
• Support audits and inspections with accurate validation documentation.
• Collaborate with QC, QA, and IT to ensure readiness for system lifecycle activities (periodic review, change control, upgrades, cyber-resilience).
• Contribute to continuous improvement initiatives to strengthen QC lab compliance.

Requirements

Tell employers what skills you have

Analytical Chemistry

Regulatory Compliance

HPLC

GMP

GAMP

Microbiology

Biotechnology

Equipment Qualification

Regulatory Requirements

Life Sciences

Laboratory

Analytical Instruments

lab equipment