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Senior Validation officer
Job in
Tabuk, Saudi Arabia
Listed on 2026-06-07
Listing for:
Tabuk Pharmaceuticals
Full Time
position Listed on 2026-06-07
Job specializations:
-
Pharmaceutical
Validation Engineer
Job Description & How to Apply Below
Key Responsibilities
- Plan & execute Computer System Validation (CSV) activities in compliance with GMP, GAMP 5, EU GMP Annex 11, and 21 CFR Part 11.
- Perform and support Data Integrity (DI) assessments and remediation activities in QC laboratories and manufacturing environments.
- Participate in and lead data analysis, gap assessments, and risk assessments related to CSV and DI.
- Support qualification activities including IQ and OQ (Equipment , system and utilities qualification knowledge for sterile and non-sterile manufacturing is advantage).
- Prepare, review, and approve CSV documentation such as URS, FS/DS, Risk Assessments, Validation Plans, Protocols, Reports, and Traceability Matrices.
- Support validation and ongoing compliance of computerized systems including:
- LIMS
- eQMS
- SAP and related modules
- Ensure validated systems remain in a state of control through change management, periodic reviews, and incident management.
- Collaborate with QC, Manufacturing, IT, Engineering, and external vendors during system implementation and upgrades.
- Support regulatory inspections and audits (EU, FDA, and other health authorities).
- Mentor junior CSV engineers and contribute to continuous improvement initiatives.
- Plan and perform data flow map in different system specially in library environments
- Bachelor’s degree in one of the following:
- Computer Science
- Information Systems
- Engineering (Computer, Electrical, or related)
- Pharmacy or Pharmaceutical Sciences (with strong IT/CSV background)
- 5-8 years of hands‑on experience in Computer System Validation within the pharmaceutical industry.
- Experience working in EU-approved pharmaceutical companies is a strong advantage.
- Strong knowledge of:
- CSV lifecycle and GAMP 5 principles
- Data Integrity principles (ALCOA+)
- EU GMP Annex 11 and 21 CFR Part 11
- Proven experience in:
- IQ and OQ execution
- Validation of LIMS, eQMS, and SAP systems
- Validation of laboratory and manufacturing computerized systems
- Experience in gap assessments, risk management, and data analysis related to CSV and DI.
- Strong documentation and technical writing skills.
Position Requirements
10+ Years
work experience
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