Benchtop IT

**Job Title**:Benchtop IT / CSV Engineer - QC Laboratory Systems
**Industry**:Life Sciences / Pharmaceutical Manufacturing

**Role Overview**:
We are seeking a **Benchtop IT / CSV Engineer**to support validation and compliance activities for **laboratory computerized systems and instruments**used in QC and analytical environments. The role involves preparing validation deliverables, executing test scripts, and ensuring that all benchtop and laboratory systems meet **GxP, Data Integrity, and 21 CFR Part 11**requirements.

**Key Responsibilities**:

- Support **Computer System Validation (CSV)**activities for QC lab systems, including benchtop instruments and associated software (e.g., Empower, LabX, Chromeleon, LabSolutions, etc.).
- Develop and execute **IQ, OQ, PQ**protocols, **test scripts**, and validation reports in line with site and corporate procedures.
- Prepare and maintain validation documentation — **URS, Risk Assessments, Traceability Matrix, Summary Reports**, and **Validation Plan**.
- Provide **technical and validation support**for instrument installation, configuration, and qualification.
- Ensure all systems and documentation comply with **GAMP 5**, **21 CFR Part 11**, **Annex 11**, and **Data Integrity (ALCOA+)**standards.
- Collaborate with **QA, IT, and Laboratory**teams for change control, deviation management, and system lifecycle maintenance.
- Participate in system reviews, backup and restore verification, and access control management for validated systems.
- Maintain audit-ready documentation and support internal or regulatory inspections.

**Qualifications & Requirements**:

- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related discipline.
- **3-6 years**of experience in **Computer System Validation (CSV)**, preferably supporting **QC / analytical laboratories**.
- Hands-on experience in **test case drafting and execution**, validation report preparation, and QA review coordination.
- Exposure to benchtop instrument qualification and validation (HPLC, GC, TOC, Balances, etc.) and related software.
- Strong understanding of **GAMP 5, 21 CFR Part 11, Annex 11**, and **Data Integrity**requirements.
- Ability to work independently and collaboratively with cross-functional teams.