Nivasoft is seeking a Validation Engineer. Duties are as shown below.
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.
Apply with 2 copies of resume to HR, Nivasoft, Inc. 241 Forsgate Dr, Suite 207, Jamesburg, NJ 08831