Senior Automation & Validation Engineer (PCS / PLC / SCADA)

Senior Automation & Validation Engineer (PCS / PLC / SCADA) Pharmaceutical Manufacturing
Foster City, CA
Long Term Rolling Contract

Position Summary

• We are seeking a highly experienced Senior Automation & Validation Engineer to lead the design, implementation, validation, and lifecycle management of manufacturing automation systems within a GMP-regulated pharmaceutical environment. This role requires a strong technical background in Process Control Systems (PCS), PLCs, SCADA, Batch Automation, and Computer System Validation (CSV).
• The successful candidate will serve as a technical leader responsible for ensuring automation systems are compliant, reliable, audit-ready, and aligned with regulatory requirements. This individual will play a critical role in automation projects from concept through qualification and ongoing operational support, with a particular focus on validation excellence and data integrity.

Key Responsibilities

Automation Systems Engineering

• Design, implement, configure, and support Process Control Systems (PCS), PLC, SCADA, HMI, and batch automation solutions for pharmaceutical manufacturing operations.
• Develop and maintain automation architectures for process equipment, utilities, packaging systems, and manufacturing facilities.
• Lead automation projects through design, commissioning, startup, qualification, and operational handover.
• Partner with Manufacturing, Engineering, Quality, Validation, and IT teams to ensure successful project execution.

PLC & SCADA Development

• Develop, modify, and troubleshoot PLC programs, control strategies, alarms, interlocks, and sequencing logic.
• Design and maintain SCADA applications, HMI graphics, alarm management, historical data collection, and reporting systems.
• Support system integration efforts involving PLCs, instrumentation, MES, historians, laboratory systems, and enterprise applications.
• Provide expert-level troubleshooting support for complex automation and process control issues.

Validation & Compliance Leadership
This position requires extensive experience leading validation activities for GMP automation systems.

• Lead Computer System Validation (CSV) activities in accordance with FDA, EMA, MHRA, GAMP 5, Annex 11, and 21 CFR Part 11 requirements.
• Author, review, and execute validation lifecycle documentation, including:

• User Requirements Specifications (URS)
• Functional Requirement Specifications (FRS)
• Design Specifications (DS)
• Configuration Specifications
• Risk Assessments
• Traceability Matrices
• IQ/OQ/PQ Protocols
• Validation Summary Reports

• Ensure automation systems meet Data Integrity (ALCOA ) requirements.
• Support regulatory inspections, client audits, and internal quality audits.
• Lead change control assessments and validation impact assessments.
• Drive validation strategy development for new and existing automation platforms.

Continuous Improvement & Lifecycle Management

• Develop and execute system lifecycle management plans for automation assets.
• Identify opportunities to improve reliability, manufacturing efficiency, data visibility, and process robustness.
• Lead root cause investigations and implement corrective and preventive actions (CAPA).
• Support cybersecurity initiatives and automation system upgrades.

Required Qualifications

• Bachelor's degree in Chemical Engineering, Computer Engineering, Automation Engineering, or related technical discipline.
• Minimum of 8 years of automation engineering experience in pharmaceutical, biotechnology, medical device, or other highly regulated manufacturing environments.
• Minimum of 8 years of direct validation experience supporting GMP automation systems.
• Demonstrated expertise in:

• Process Control Systems (PCS)
• PLC Programming
• SCADA Systems
• Industrial Networking
• Computer System Validation (CSV)
• GMP Manufacturing Operations

• Proven experience leading automation projects from concept through validation and production support.

Preferred Technical Experience
PCS / DCS Platforms

• Emerson DeltaV
• Siemens PCS7
• ABB 800xA
• Client Experion
• Rockwell PlantPAx

PLC Platforms

• Allen-Bradley ControlLogix
• CompactLogix
• Siemens S7
• Schneider Electric

SCADA & HMI Platforms

• Ignition SCADA
• FactoryTalk View SE
• Wonderware System Platform
• Siemens WinCC
• iFIX

Systems Integration

• OPC UA
• Modbus TCP/IP
• Ethernet/IP
• Profinet
• MQTT

Regulatory & Validation Expertise Required. Candidates must demonstrate strong working knowledge of:

• FDA 21 CFR Part 11
• EU Annex 11
• GAMP 5
• cGMP Regulations
• Data Integrity Principles (ALCOA )
• Computer System Validation (CSV)
• Commissioning, Qualification, and Validation (CQV)
• ISA-88 Batch Standards
• ISA-95 Manufacturing Integration Standards
• Change Control and Quality Systems

Preferred Candidate Profile
The ideal candidate is a hands-on Automation and Validation SME who has successfully deployed and validated PCS, PLC, and SCADA systems in pharmaceutical manufacturing facilities. They possess the technical capability to troubleshoot complex control systems while also demonstrating deep expertise in validation strategy, risk-based compliance, and regulatory expectations.
This individual is comfortable interacting with Quality Assurance, Validation, Regulatory Affairs, and Health Authority inspectors, and is capable of independently leading automation validation efforts across multiple manufacturing processes and facilities.

Key Attributes

• Strong validation and documentation skills
• Exceptional troubleshooting capability
• Deep pharmaceutical GMP knowledge
• Project leadership experience
• Strong communication and stakeholder management skills
• Ability to influence cross-functional teams and drive compliant automation solutions

The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.