Job Description

Role Overview

We are seeking a QC Engineer with strong experience in

Computer System Validation (CSV)

for analytical laboratory instruments /equipment. The role ensures compliance with 21 CFR Part 11, data integrity, and global validation standards in a regulated GMP environment.

Key Responsibilities

Lead CSV activities for

analytical equipment or instruments and lab computerized systems

(e.g., HPLC, GC, UV, LIMS, Empower). Develop and execute validation deliverables: URS, risk assessments, IQ/OQ/PQ, RTM, and summary reports. Ensure compliance with

21 CFR Part 11, Annex 11, ALCOA+

principles, and data integrity controls. Evaluate and validate audit trails, security settings, and user access controls. Support integration between instrument, PC, network, and enterprise systems. Draft, review, and maintain SOPs, validation documentation, and audit readiness materials. Contribute to lifecycle management of systems including periodic reviews, upgrades, and change control. Collaborate with QA, QC, and IT to support inspection readiness and continuous improvement.

Requirements

Requirements

Bachelor's degree in Chemistry, Life Sciences, Engineering, or related discipline.

5-10 years' experience

in

analytical instrument/equipment CSV

within pharmaceutical/biotech QC labs. Strong knowledge of

cGMP, GAMP 5, 21 CFR Part 11, Annex 11

. Hands-on experience with

microbiology analytical equipment

is an advantage. Familiarity with electronic validation tools (e.g.,

Kneat

) is preferred. * Strong documentation, troubleshooting, and cross-functional collaboration skills.