IT Analyst

We are seeking an experienced IT Analyst with expertise in SAP, MES, or Computer System Validation (CSV) to join pharma project delivery team. In this role, you will play a critical part in implementing, validating, and optimizing enterprise IT/OT systems within regulated pharmaceutical manufacturing environments.

Whether your background is rooted in ERP integration, shop-floor MES execution, or GxP quality and compliance, you will work closely with cross-functional teams to ensure seamless project execution that meets stringent regulatory standards (FDA, EMA, HAS).

Key Responsibilities

- Lead or support the implementation, upgrade, and optimization of enterprise applications (SAP, MES, or related manufacturing IT systems) for pharmaceutical clients.

- Prepare, execute, and review validation lifecycle documentation (UARS, FS, DQ, IQ, OQ, PQ, VSR) in accordance with GAMP 5, 21 CFR Part 11, and Annex 11 guidelines.

- Partner with business stakeholders to translate manufacturing, supply chain, or operational requirements into functional IT solutions.

- Ensure all systems comply with GxP regulations and strict Data Integrity standards throughout the project lifecycle.

- Coordinate between business end-users, IT/OT vendors, quality assurance, and project management teams to deliver projects on time and within budget.

- Minimum 5 years of hands-on experience in one or more of the following core areas within the Pharmaceutical, Life Sciences or Manufacturing sector or projects.

- Functional/technical expertise in relevant SAP modules (e.g., SAP QM, MM, PP-PI, PM, or S/4HANA implementation).

- Hands-on experience with Manufacturing Execution Systems (e.g., Werum PAS-X, Syncade, Rockwell, or Siemens Opcenter).

- Deep experience leading Computer System Validation, lifecycle documentation, and GxP compliance.

- Strong understanding of GAMP 5 guidelines, 21 CFR Part 11, EU Annex 11, and GxP regulatory requirements.

- Bachelor’s degree in Computer Science, Information Technology, Engineering, Pharmacy, or a related discipline.

- Excellent analytical, problem-solving, and cross-functional communication skills.