Job Summary
We are seeking an experienced DeltaV Application Programmer to design, configure, program, and maintain Emerson DeltaV Distributed Control System (DCS) applications within our clients GMP-regulated pharmaceutical manufacturing facility. The ideal candidate combines strong DeltaV batch/continuous software configuration skills with hands-on knowledge of DeltaV hardware architecture and industrial networking and is comfortable working within a validated (CSV), GMP-compliant environment where documentation, change control, and data integrity are critical. This role supports process automation for API, drug product, biologics, and/or fill-finish operations, ensuring systems remain compliant, reliable, and audit-ready.
Job Responsibilities:
Design, develop, test, and deploy DeltaV control strategies, including continuous control modules, phase logic, S88-based batch recipes, and sequential function charts (SFCs), for GMP manufacturing processes.
Configure and maintain DeltaV Operator Interface (Control Studio, Process History View, and Dynamo graphics/HMI displays) to support safe, compliant, and efficient plant operations.
Build and maintain DeltaV database configurations, including module templates, alarms, historian tags, and I/O assignments, in accordance with site data integrity standards (ALCOA+).
Configure and troubleshoot DeltaV hardware including MD/SD/SQ series controllers, CHARM I/O cards and terminals, workstations, and redundant controller pairs installed in classified and non-classified manufacturing areas.
Support and maintain DeltaV network architecture, including the Control Network (fiber/copper), Application Station connectivity, redundant network switches, and integration with plant-wide Ethernet/IT and MES/ERP networks.
Perform system health checks, diagnostics, and troubleshooting of hardware faults, network communication failures, and controller/I-O card issues, minimizing unplanned downtime in production areas.
Execute DeltaV software and firmware upgrades, patches, and system backups under formal change control, in coordination with IT/OT cybersecurity and Quality/Validation requirements.
Develop and maintain functional specifications, control narratives, I/O lists, and system documentation to support GMP documentation requirements (URS, FS, DS, traceability matrices).
Author and execute IQ/OQ/PQ protocols and support Computer System Validation (CSV) activities for new or modified DeltaV applications, per site validation policies and 21 CFR Part 11 / Annex 11 requirements.
Support Electronic Batch Record (EBR) configuration and integration between DeltaV and MES/Historian systems (e.g., Syncade, PAS-X, DeltaV Batch Historian).
Participate in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, and startup activities for new or modified control systems, including automation for new drug product/API introductions.
Collaborate with process engineering, QA, validation, and automation teams to implement new control strategies and modifications via Management of Change (MOC) and deviation/CAPA processes.
Provide troubleshooting support and root cause analysis for control system malfunctions, including investigation support for deviations impacting batch disposition, and on-call/after-hours support as needed.
Maintain system configurations in accordance with data integrity, audit trail, and electronic signature requirements; support internal audits and regulatory inspections (FDA, EMA, etc.) as a system SME.
Ensure compliance with cybersecurity standards (e.g., IEC 62443) for DCS network and workstation configurations within a validated environment.
Required Qualifications:
10+ years of hands-on experience programming and configuring Emerson DeltaV DCS systems, preferably within a GMP-regulated pharmaceutical, biotech, or life sciences manufacturing environment.
Strong working knowledge of DeltaV software tools: Control Studio, Recipe Studio, Diagnostics, Explorer, and Batch Historian, including S88-based batch/phase logic development.
Solid understanding of DeltaV hardware components: controllers (MD, SD, SZ, SQ series), CHARM I/O, Smart Switches, Application/Professional Plus Stations, and redundant power supplies.
Practical knowledge of DeltaV networking architecture, including Control Network topology, VLAN segmentation, redundant network design, and integration points with plant IT/MES networks.
Familiarity with industrial communication protocols (e.g., Modbus, HART, Foundation Fieldbus, Profibus, OPC/OPC-UA).
Working knowledge of GMP requirements, 21 CFR Part 11 (electronic records/signatures), and Computer System Validation (CSV) practices, including IQ/OQ/PQ documentation.
Understanding of P&IDs, control narratives, cause & effect diagrams, and instrumentation loop drawings.
Experience working within a formal change control (MOC) and quality management system (QMS) environment.
Strong analytical and troubleshooting skills for diagnosing hardware, software, and network-level issues without compromising product quality or batch integrity.
Excellent written and verbal communication skills for authoring GMP documentation and collaborating cross-functionally with Quality, Validation, and Manufacturing teams.
Preferred Qualifications:
Experience in DeltaV integration with MES platforms (e.g., Werum PAS-X, Syncade, POMSnet) for Electronic Batch Records.
Experience with virtualized DeltaV environments and DeltaV system redundancy design.
Familiarity with cybersecurity hardening practices for DCS environments (patching, whitelisting, network segmentation) within a validated 21 CFR Part 11 system.
Experience supporting FDA/EMA regulatory inspections or internal quality audits as an automation system SME.
Working knowledge of AMS Device Manager or other asset management software.
Familiarity with GAMP 5 risk-based approach to CSV.
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コグニザントについて
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