IT Validation Specialist
We are seeking an experienced professional to join our team in a key role within the pharmaceutical sector.
About the Role
This position is critical in ensuring that all IT systems and software comply with regulatory standards, operational requirements, and industry best practices.
The ideal candidate will have a strong background in IT Infrastructure, computer system validation (CSV) and regulatory compliance with prior experience in a highly regulated environment.
Responsibilities
* Manage the qualification of IT systems, including hardware, software, and infrastructure within a GMP lab setting.
* Validate software applications used in manufacturing, quality control, and other pharmaceutical processes.
* Collaborate with software vendors to ensure system validation documentation is complete and accurate.
* Manage the lifecycle of validated software, including upgrades and decommissioning.
* Perform periodic reviews of validated systems to ensure continued compliance.
* Develop and maintain traceability matrices to ensure alignment with user requirements.
* Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
* Author, review and approve validation documentation, including validation plans, reports, and risk assessments.
* Ensure all validation activities comply with regulatory standards such as Gx P, FDA 21 CFR Part 11, and EMA guidelines.
* Prepare validation summaries, deviation reports, and corrective/preventive action (CAPA) plans.
Requirements
* Bachelor's degree in Computer Science, Information Technology, or a related field.
* 3+ years of experience in IT validation, preferably in a pharmaceutical or regulated environment.
* In-depth knowledge of Gx P regulations, FDA 21 CFR Part 11, and other relevant standards.
* Experience with validation of ERP, LIMS, MES, and other pharma-specific IT systems.
* Strong understanding of software development lifecycle (SDLC) and validation best practices.
* Familiarity with IT infrastructure, database management, and networking in a validated environment.
* Excellent problem-solving, analytical, and organizational skills.
* Strong written and verbal communication skills, with the ability to present validation results to diverse audiences.
What We Offer
We understand that our people are our greatest asset.
We take care of them through a Total Rewards package.
This includes great personal benefits and professional growth opportunities.
We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported.
We do not discriminate on the basis of race, colour, religion, sex, national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law.
We encourage applications from all qualified candidates, regardless of background.
We strive to create a welcoming environment for everyone.