Engineer II, Automation Validation

Role: Support Automation Validation and Computerized Systems Validation (CSV) functions within a biopharma manufacturing site, ensuring regulatory compliance, operational efficiency, and successful project delivery. Responsibilities: develop and approve cGMP validation documents, lead validation activities for automation systems (PLC, HMI, SCADA, DCS, vision, data acquisition), participate in system design reviews, perform risk assessments, manage validation projects and resources, review equipment specifications, and investigate validation discrepancies. Requirements: BS in engineering or scientific discipline (pharmaceutical sciences, chemistry, engineering), minimum 3-4 years validation experience in FDA-regulated biotech/pharma manufacturing, knowledge of cGMP, data integrity, risk-based approaches, and sterile/aseptic processing. Preferred: experience with CSV, automation validation, and IT tools like Microsoft Office and SAP. HighValue: validation of automated manufacturing systems supporting sterile biotech processes, compliance with GxP, and involvement in audits. Work setup: site-based with gowning in manufacturing suites, with up to 5% travel.