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Mechanical Engineer Synerfac Technical Staffing
Langhorne, PA4 days ago
- $80,000–$120,000 Per Year
- Employee
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Skills
- ABB (Asea Brown Boveri)unmatched
- Access Controlunmatched
- Allen-Bradleyunmatched
- Automationunmatched
- Change Controlunmatched
- Commissioningunmatched
- Computer Softwareunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Data Qualityunmatched
- Data Recoveryunmatched
- Documentationunmatched
- Documentation Planunmatched
- ERP (Enterprise Resource Planning)unmatched
- Environmental Managementunmatched
- GLP (Good Laboratory Practices)unmatched
- GMP (Good Manufacturing Practices)unmatched
- GxPunmatched
- Human Machine Interface (HMI)unmatched
- Laboratory Information Management System (LIMS)unmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Programmable Logic Controller (PLC)unmatched
- Protocol Analysisunmatched
- Requirements Managementunmatched
- Requirements Validation/Verificationunmatched
- Riskunmatched
- Risk Analysisunmatched
- Risk Managementunmatched
- Root Cause Analysisunmatched
- SQL (Structured Query Language)unmatched
- Software Patchesunmatched
- Supervisory Control and Data Acquisition (SCADA)unmatched
- System Validationunmatched
- Test Requirementsunmatched
- Test Scriptsunmatched
- Test Strategyunmatched
- Testingunmatched
- Traceabilityunmatched
- Validation Documentationunmatched
- Validation Planunmatched
- Validation Testingunmatched
- Writing Skillsunmatched
Description
Job Summary:
- Shop Floor CSV/CSA Lead/Engineer responsible for leading and executing validation deliverables across the lifecycle in regulated manufacturing and laboratory GMP/GLP environments.
- The role includes automation/controls validation, risk-based validation activities, audit readiness, data integrity compliance, and coordination with IT/OT teams for validated systems.
- Lead and execute validation deliverables including risk assessment, validation planning, requirements traceability, test strategy, test execution, deviation management, and final reporting/release.
- Apply a risk-based approach (GxP impact, patient/product risk, data integrity) to define validation scope and testing depth.
- Author and review validation documentation including Compliance Plan/Test Protocols, Risk Assessments, Requirements and Traceability Matrix (RTM), test scripts, test summaries, and compliance reports.
- Validate PLC logic changes including configuration, recipes, alarms, interlocks, and permissives.
- Validate SCADA/HMI functions including screens, alarms, trends, historian interfaces, user roles, and electronic records.
- Support MES/PLC/SCADA/ERP interface validation activities.
- Ensure data integrity controls for automation data including audit trails, access controls, backups/restore, record retention, time synchronization, and change control.
- Support audits and inspections by providing validation documentation and evidence of control effectiveness.
- Review and approve vendor documentation including FAT/SAT and integrate into validation packages.
- Participate in deviation investigations, root cause analysis, and CAPA activities related to validated systems.
- Coordinate with IT/OT teams on system hardening, patching strategies, backups, access management, and network segmentation impacts to validated systems.
- Validate interfaces including PLC SCADA, historian, MES, and LIMS controlled data flows.
- Work with technologies including Siemens, Rockwell/Allen-Bradley, Schneider, ABB PLCs, Ignition, Wonderware/AVEVA, FactoryTalk View, WinCC, iFIX, OSIsoft PI, OPC/OPC UA, and SQL-based integrations.
- Experience in automation/controls and validation/qualification within regulated or quality-managed environments.
- Hands-on understanding of PLC/SCADA architectures, control strategies, alarms, and HMI design concepts.
- Strong documentation skills with ability to produce audit-ready validation evidence.
- Working knowledge of change control, deviation handling, and risk management.
- Experience with GxP environments and computerized system validation (CSV) / computer software assurance (CSA) approaches.
- Familiarity with electronic records/e-signatures expectations and data integrity principles.
- Experience with commissioning and FAT/SAT testing.
- Able to work in Manufacturing and Laboratory GMP/GLP facilities at client site.
Numbers & Facts
| Location | Raritan, NJ |
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