About the job
Join our team as a Senior Computer System Validation (CSV) Specialist! We are seeking a talented MES Engineer with extensive experience in Manufacturing Execution Systems (MES), specifically Syncade, to enhance our biologics manufacturing facility. In this role, you will be pivotal in the planning, authoring, executing, and reviewing of validation deliverables while adhering to FDA, EMA, ICH, and GAMP 5 guidelines. You will collaborate closely with Quality, IT, Engineering, and Manufacturing teams to ensure the MES system operates in a validated, compliant, and reliable manner throughout its lifecycle.
Key Responsibilities:
- Lead and execute CSV initiatives for MES (Syncade) in a GMP environment focused on biologics.
- Develop and maintain comprehensive validation documentation, including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Risk Assessments, and IQ/OQ/PQ protocols.
- Collaborate with Manufacturing and Quality teams to validate MES recipes, workflows, and master batch records.
- Conduct impact assessments and manage change controls for system upgrades, patches, and enhancements.
- Ensure compliance of CSV deliverables with GAMP 5, 21 CFR Part 11, Annex 11, and other relevant regulations.
- Work alongside IT and Engineering teams for effective system integrations (e.g., LIMS, ERP/SAP, DeltaV, PI Historian).
- Provide support during regulatory audits (FDA, EMA, MHRA, etc.) and customer inspections.
- Mentor junior validation engineers and facilitate knowledge sharing on CSV best practices.
- Contribute to the continuous improvement of MES validation strategies, procedures, and templates.
