DeltaV Application Programmer
Job Description
We are currently looking for a skilled DeltaV Application Programmer to take on the responsibilities of designing, configuring, programming, and maintaining Emerson DeltaV Distributed Control System (DCS) applications in a pharmaceutical manufacturing facility that adheres to GMP regulations. The ideal candidate will possess robust DeltaV batch and continuous software configuration capabilities, along with practical experience in DeltaV hardware architecture and industrial networking. This role requires comfort in a validated (CSV) and GMP-compliant setting, where documentation, change control, and data integrity are essential. This position is pivotal in supporting process automation for API, drug product, biologics, and/or fill-finish operations, guaranteeing that systems are compliant, dependable, and audit-ready.
Key Responsibilities
. Design, develop, test, and implement DeltaV control strategies, including continuous control modules, phase logic, S88-based batch recipes, and sequential function charts (SFCs), tailored for GMP manufacturing processes.
. Configure and maintain the DeltaV Operator Interface (Control Studio, Process History View, and Dynamo graphics/HMI displays) to facilitate safe, compliant, and efficient operations within the plant.
. Build and uphold DeltaV database configurations, including module templates, alarms, historian tags, and I/O assignments, in alignment with site data integrity standards (ALCOA+).
. Configure and troubleshoot DeltaV hardware, such as MD/SD/SQ series controllers, CHARMI/O cards and terminals, workstations, and redundant controller pairs in classified and non-classified manufacturing zones.
. Support and sustain DeltaV network architecture, which includes the Control Network (fiber/copper), Application Station connectivity, redundant network switches, and integration with plant-wide Ethernet/IT and MES/ERP networks.
. Conduct system health checks, diagnostics, and troubleshooting of hardware faults, network communication issues, and controller/I-O card malfunctions to minimize unplanned downtime in production areas.
. Execute DeltaV software and firmware upgrades, patches, and system backups under structured change control, coordinating with IT/OT cybersecurity and Quality/Validation requirements.
. Develop and maintain functional specifications, control narratives, I/O lists, and system documentation to meet GMP documentation requirements (URS, FS, DS, traceability matrices).
. Write and execute IQ/OQ/PQ protocols and assist with Computer System Validation (CSV) activities for new or modified DeltaV applications, adhering to site validation policies and 21 CFR Part 11 / Annex 11 standards.
. Assist with Electronic Batch Record (EBR) configuration and the integration of DeltaV with MES/Historian systems (e.g., Syncade, PAS-X, DeltaV Batch Historian).
. Engage in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, and startup activities for new or modified control systems, particularly for new drug product/API introductions.
. Collaborate with process engineering, QA, validation, and automation teams to implement new control strategies and modifications through Management of Change (MOC) and deviation/CAPA processes.
. Provide troubleshooting support and root cause analysis for control system failures, including investigation assistance for deviations that affect batch disposition, and offer on-call/after-hours support as required.
. Maintain system configurations in compliance with data integrity, audit trail, and electronic signature requirements, supporting internal audits and regulatory inspections (FDA, EMA, etc.) as a system SME.
. Ensure adherence to cybersecurity standards (e.g., IEC 62443) for DCS network and workstation configurations within a validated environment.
Required Qualifications
. Bachelor's degree in Electrical Engineering, Instrumentation & Control, Chemical Engineering, Computer Engineering, or a related field, or equivalent practical experience.
. Over 10 years of hands-on experience in programming and configuring Emerson DeltaV DCS systems, ideally within a GMP-regulated pharmaceutical, biotech, or life sciences manufacturing environment.
. Extensive knowledge of DeltaV software tools: Control Studio, Recipe Studio, Diagnostics, Explorer, and Batch Historian, including S88-based batch/phase logic development.
. Strong understanding of DeltaV hardware components: controllers (MD, SD, SZ, SQ series), CHARM I/O, Smart Switches, Application/Professional Plus Stations, and redundant power supplies.
. In-depth knowledge of DeltaV networking architecture, including Control Network topology, VLAN segmentation, redundant network design, and integration with plant IT/MES networks.
. Familiarity with industrial communication protocols (e.g., Modbus, HART, Foundation Fieldbus, Profibus, OPC/OPC-UA).
. Proficient understanding 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 in a structured change control (MOC) and quality management system (QMS) environment.
. Strong analytical and troubleshooting abilities for diagnosing hardware, software, and network-level issues while maintaining product quality and batch integrity.
. Excellent written and verbal communication skills for producing GMP documentation and collaborating across various teams, including Quality, Validation, and Manufacturing.
Preferred Qualifications
. Experience integrating DeltaV 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 assisting with FDA/EMA regulatory inspections or internal quality audits as a subject matter expert in automation systems.
. Working knowledge of AMS Device Manager or other asset management software.
. Familiarity with the GAMP 5 risk-based approach to CSV.
