Nivasoft India

Qualifications Bachelor s/Master s degree in Chemical/Biomedical Engineering, Pharmaceutical/ Regulatory Affairs or Equivalent. Description Nivasoft is seeking a Validation Engineer. Duties are as shown below. Job Type Full Time Job Duties Write and create automation periodic evaluation reports for automated systems used in commercial manufacturing, analytical testing and training/document tracking/retention. Author test plans/test cases / matrices / scripts / technical evaluations and IOQ documents to support Validation activities. Author, edit, review, evaluate and maintain system validation documentation (Such as user requirement Specifications, functional Specifications, Software Design Specification etc) following GAMP 5 guidance. Author, edit, review, evaluate and maintain department CGMP documentation standard operating procedures, procedural quizzes, work instructions, standard engineering specifications, job aids, FMEA, gap analysis, memos/addendums/amendments, on the job training documentation, instructor-led training material, forms/templates/manuals, equipment/system genealogy/lineage documentation etc. Create and review documents designed to explain and test automated process control systems and laboratory automation. Perform and document investigations and risk assessments of engineering and automation related deviations and anomalies. Write and oversee review/approvals for modifications/change controls revision histories to document (Standard operating procedures, work instructions, job aids, etc.) Create and review documents designed to explain and test automated process control systems and laboratory automation. Create and maintain technical writing standards for the automation and Engineering unit