Senior Control Systems Engineer

Job Title:

Automation & Control Systems Engineer (Pharma / Medical Device) Position Summary The Automation & Control Systems Engineer is responsible for the design, development, implementation, validation, and lifecycle support of automated systems within pharmaceutical and medical device manufacturing environments. This role focuses on

SCADA, PLC, DCS

(e.g., DeltaV), and related control technologies to ensure compliant, reliable, and efficient production processes aligned with regulatory requirements such as FDA, GMP, and ISO standards. Key Responsibilities Automation System Design & Implementation Design, develop, and configure automation systems using: PLC platforms (e.g., Allen-Bradley ControlLogix, Siemens S7) SCADA systems (e.g., Wonderware, Ignition, FactoryTalk) DCS systems (e.g., DeltaV, PCS7) Develop control strategies, functional specifications, and system architecture. Create and maintain

HMI/SCADA

interfaces for manufacturing processes. Integrate automation systems with MES, historians, and enterprise systems. Programming & Configuration Develop and troubleshoot PLC logic (Ladder, Function Block, Structured Text). Configure

SCADA/DCS

systems including alarms, trends, and reporting. Implement batch control systems (ISA-88 standards preferred). Develop and maintain reusable code libraries and standards. Validation & Compliance Lead or support Computer System Validation (CSV) activities: IQ (Installation Qualification) OQ (Operational Qualification) PQ (Performance Qualification) Ensure compliance with:

FDA 21 CFR

Part 11 (data integrity, audit trails) GxP (GMP, GAMP 5)

ISO 13485

(medical devices) Develop validation documentation: URS (User Requirements Specification) FRS (Functional Requirements Specification) DS (Design Specification) Traceability matrices Commissioning & Startup Support factory acceptance testing (FAT) and site acceptance testing (SAT). Lead system commissioning and startup activities. Troubleshoot issues during installation and production ramp-up. Provide on-site support during critical production phases. Maintenance & Continuous Improvement Provide ongoing support for automation systems in production. Diagnose and resolve control system issues and downtime events. Implement system upgrades, patches, and lifecycle management. Identify and drive process improvements, optimization, and automation enhancements. Documentation & Standards Develop and maintain engineering documentation: P&IDs, control narratives, loop diagrams Network architecture diagrams Ensure adherence to company and industry standards. Maintain change control documentation (e.g., CAPA, deviations).

Cross-Functional Collaboration Work closely with:

Manufacturing Quality Assurance Validation teams IT/OT teams Participate in audits and regulatory inspections. Provide technical training to operators and maintenance staff. Required QualificationsEducation Bachelor's degree in: Electrical Engineering Automation Engineering Control Systems Engineering Chemical Engineering (with automation focus) Experience 3-10+ years of experience in automation within: Pharmaceutical manufacturing Biotechnology Medical device industry Technical Skills Strong experience with: PLC programming (Allen-Bradley, Siemens) SCADA systems (Ignition, Wonderware, FactoryTalk) DCS platforms (DeltaV preferred)

Knowledge of:

Industrial communication protocols (EtherNet/IP, Modbus, Profibus) Batch processing (ISA-88) Data historians (OSIsoft PI, etc.) Familiarity with MES integration and serialization systems (for pharma/med device) Regulatory Knowledge Deep understanding of: GMP / GxP environments FDA regulations (21 CFR Part 11) GAMP 5 guidelines Data integrity principles (ALCOA+) Preferred Qualifications Experience with: DeltaV Batch or Recipe Studio Vision systems (for medical devices) Robotics integration

Certification:

Certified Automation Professional (CAP) PMP (Project Management Professional) is a plus Experience with cybersecurity in industrial control systems (ICS) Soft Skills Strong analytical and problem-solving skills Excellent communication and documentation abilities Ability to work in cross-functional, regulated environments Detail-oriented with a focus on quality and compliance Work Environment Combination of office, manufacturing floor, and lab environments May require: On-call support Travel (for site support, FAT/SAT) Work in cleanroom environments (pharma/med device) Key Performance Indicators (KPIs) System uptime and reliability Successful validation and audit outcomes Project delivery timelines and budget adherence Reduction in downtime and process deviations

Tools & Technologies PLC:

Allen-Bradley, Siemens SCADA:

Ignition, Wonderware, FactoryTalk DCS:

DeltaV, PCS7

Version Control:

Git, SVN Documentation:

AutoCAD, Visio Validation tools and electronic QMS systems

Pay:

$30.00

• $70.

00 per hour

Work Location:

In person Senior Control Systems Engineer Miami, FL 33134 $30

• $70 an hour
• Contract $30
• $70 an hour

•

Contract Job Title:

Automation & Control Systems Engineer (Pharma / Medical Device) Position Summary The Automation & Control Systems Engineer is responsible for the design, development, implementation, validation, and lifecycle support of automated systems within pharmaceutical and medical device manufacturing environments. This role focuses on

SCADA, PLC, DCS

(e.g., DeltaV), and related control technologies to ensure compliant, reliable, and efficient production processes aligned with regulatory requirements such as FDA, GMP, and ISO standards. Key Responsibilities Automation System Design & Implementation Design, develop, and configure automation systems using: PLC platforms (e.g., Allen-Bradley ControlLogix, Siemens S7) SCADA systems (e.g., Wonderware, Ignition, FactoryTalk) DCS systems (e.g., DeltaV, PCS7) Develop control strategies, functional specifications, and system architecture. Create and maintain

HMI/SCADA

interfaces for manufacturing processes. Integrate automation systems with MES, historians, and enterprise systems. Programming & Configuration Develop and troubleshoot PLC logic (Ladder, Function Block, Structured Text). Configure

SCADA/DCS

systems including alarms, trends, and reporting. Implement batch control systems (ISA-88 standards preferred). Develop and maintain reusable code libraries and standards. Validation & Compliance Lead or support Computer System Validation (CSV) activities: IQ (Installation Qualification) OQ (Operational Qualification) PQ (Performance Qualification) Ensure compliance with:

FDA 21 CFR

Part 11 (data integrity, audit trails) GxP (GMP, GAMP 5)

ISO 13485

(medical devices) Develop validation documentation: URS (User Requirements Specification) FRS (Functional Requirements Specification) DS (Design Specification) Traceability matrices Commissioning & Startup Support factory acceptance testing (FAT) and site acceptance testing (SAT). Lead system commissioning and startup activities. Troubleshoot issues during installation and production ramp-up. Provide on-site support during critical production phases. Maintenance & Continuous Improvement Provide ongoing support for automation systems in production. Diagnose and resolve control system issues and downtime events. Implement system upgrades, patches, and lifecycle management. Identify and drive process improvements, optimization, and automation enhancements. Documentation & Standards Develop and maintain engineering documentation: P&IDs, control narratives, loop diagrams Network architecture diagrams Ensure adherence to company and industry standards. Maintain change control documentation (e.g., CAPA, deviations).

Cross-Functional Collaboration Work closely with:

Manufacturing Quality Assurance Validation teams IT/OT teams Participate in audits and regulatory inspections. Provide technical training to operators and maintenance staff. Required QualificationsEducation Bachelor's degree in: Electrical Engineering Automation Engineering Control Systems Engineering Chemical Engineering (with automation focus) Experience 3-10+ years of experience in automation within: Pharmaceutical manufacturing Biotechnology Medical device industry Technical Skills Strong experience with: PLC programming (Allen-Bradley, Siemens) SCADA systems (Ignition, Wonderware, FactoryTalk) DCS platforms (DeltaV preferred)

Knowledge of:

Industrial communication protocols (EtherNet/IP, Modbus, Profibus) Batch processing (ISA-88) Data historians (OSIsoft PI, etc.) Familiarity with MES integration and serialization systems (for pharma/med device) Regulatory Knowledge Deep understanding of: GMP / GxP environments FDA regulations (21 CFR Part 11) GAMP 5 guidelines Data integrity principles (ALCOA+) Preferred Qualifications Experience with: DeltaV Batch or Recipe Studio Vision systems (for medical devices) Robotics integration

Certification:

Certified Automation Professional (CAP) PMP (Project Management Professional) is a plus Experience with cybersecurity in industrial control systems (ICS) Soft Skills Strong analytical and problem-solving skills Excellent communication and documentation abilities Ability to work in cross-functional, regulated environments Detail-oriented with a focus on quality and compliance Work Environment Combination of office, manufacturing floor, and lab environments May require: On-call support Travel (for site support, FAT/SAT) Work in cleanroom environments (pharma/med device) Key Performance Indicators (KPIs) System uptime and reliability Successful validation and audit outcomes Project delivery timelines and budget adherence Reduction in downtime and process deviations

Tools & Technologies PLC:

Allen-Bradley, Siemens SCADA:

Ignition, Wonderware, FactoryTalk DCS:

DeltaV, PCS7

Version Control:

Git, SVN Documentation:

AutoCAD, Visio Validation tools and electronic QMS systems

Pay:

$30.00

• $70.

00 per hour

Work Location:

In person