· Create and maintain technical writing standards for the Automation and Engineering unit.
· Write and create automation periodic evaluation reports for automated systems used in commercial pharma manufacturing, analytical testing and training/document tracking/retention.
· Perform and document investigations and risk assessments of pharmaceutical complex related deviations and anomalies.
· Write and oversee specific validation review/approvals for modifications/change controls/revision histories to documents (standard specialized operating procedures, work instructions, job aids, etc,).
· Create and review documents designed to explain and test automated validation process control systems and laboratory automation.
· Author test plans/test cases/matrices/scripts/pharmaceutical evaluations and IOS~ documents to support validation activities.
· Author, edit, review and maintain system design 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 specialized 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.
This position requires a minimum of Bachelor Degree in Pharmaceutical, Drug Regulatory Affairs, Chemistry, or related field.