Senior CSV Lead - Syncade MES & Automation Validation

EFOR; Bend (OR); On-site; USD 120,000 - 160,000; Full time

Job summary

EFOR seeks a Senior CSV Lead to support a major CAPEX project at a regulated pharma/biotech site. You will own Computer System Validation across the automation landscape, including SCADA, Allen Bradley PLCs, and Emerson Syncade MES, working with engineering, manufacturing, quality, and IT/OT teams.

You will guide documentation from design through implementation and qualification, drive validation activities, ensure 21 CFR Part 11 compliance, and generate monthly KPIs for leadership.

Qualifications

• Bachelor's or master's degree in engineering, computer science, life sciences, or a related technical field
• 10+ years in Computer System Validation and Manufacturing Automation within pharma, biotech, or life sciences
• Track record leading CSV on large CAPEX projects
• Strong experience with SCADA systems, Allen Bradley PLCs, and Emerson Syncade MES
• Proven expertise taking Syncade MES and SCADA systems from implementation through commissioning, validation, and testing
• Deep experience authoring, reviewing, approving, and executing CSV documentation across the validation lifecycle
• Grounding in SDLC, Data Integrity, 21 CFR Part 11, EU Annex 11, and GAMP 5
• Experience with software changes and validation deliverables through SDLC
• Experience with Kneat Validation Platform
• Strong analytical and troubleshooting skills, and the ability to work independently while collaborating across teams

Responsibilities

• Lead CSV activities across the full system lifecycle for a large CAPEX project
• Review and approve lifecycle documentation, including Validation Plans, System Classification, System CSV Plan and Report, Data Integrity Risk Assessments, URS, FS/FDS, Configuration Specifications, IQ/OQ Protocols, Traceability Matrices, and Qualification Final Reports
• Lead validation for Syncade MES implementation, configuration, testing, and deployment
• Drive commissioning and validation of Syncade MES applications
• Validate automation systems tied to Allen Bradley PLCs and related manufacturing equipment
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity principles, and site procedures
• Manage and document Software Development and Design Changes throughout the SDLC
• Participate in FAT, SAT, commissioning, startup, and qualification activities
• Act as CSV SME, guiding the documentation team and CQ/CSV colleagues throughout the project
• Generate monthly KPIs for CQ/CSV leadership

Skills

CSV validation

GAMP 5

Data Integrity

SCADA

Allen-Bradley PLCs

Emerson Syncade MES

SDLC

Documentation

Regulatory compliance

Education

Bachelor's or master's in engineering or related field

Tools

Kneat Validation Platform

Syncade MES

SCADA systems

Allen Bradley PLCs

Job description

We're looking for a Senior CSV Lead to support a major CAPEX project at a regulated pharmaceutical and biotechnology manufacturing site. This role owns Computer System Validation activities across a complex automation landscape, including SCADA, Allen Bradley PLCs, and Emerson Syncade MES.

You’ll work hands on, leading validation from design through implementation and qualification, while partnering closely with engineering, automation, manufacturing, quality, and IT/OT teams to keep systems compliant and business ready.

What you’ll do

• Lead CSV activities across the full system lifecycle for a large CAPEX project
• Review and approve lifecycle documentation, including Validation Plans, System Classification, System CSV Plan and Report, Data Integrity Risk Assessments, URS, FS/FDS, Configuration Specifications, IQ/OQ Protocols, Traceability Matrices, and Qualification Final Reports
• Lead validation for Syncade MES implementation, configuration, testing, and deployment
• Drive commissioning and validation of Syncade MES applications
• Validate automation systems tied to Allen Bradley PLCs and related manufacturing equipment
• Ensure compliance with 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity principles, and site procedures
• Manage and document Software Development and Design Changes throughout the SDLC
• Participate in FAT, SAT, commissioning, startup, and qualification activities
• Act as CSV SME, guiding the documentation team and CQ/CSV colleagues throughout the project
• Generate monthly KPIs for CQ/CSV leadership

What you bring

• Bachelor's or master's degree in engineering, computer science, life sciences, or a related technical field
• 10+ years in Computer System Validation and Manufacturing Automation within pharma, biotech, or life sciences
• A track record leading CSV on large CAPEX projects
• Strong, practical experience with SCADA systems, Allen Bradley PLCs, and Emerson Syncade MES
• Proven expertise taking Syncade MES and SCADA systems from implementation through commissioning, validation, and testing
• Deep experience authoring, reviewing, approving, and executing CSV documentation across the validation lifecycle
• Solid grounding in SDLC, Data Integrity, 21 CFR Part 11, EU Annex 11, and GAMP 5
• Experience managing software changes and validation deliverables through SDLC
• Experience with the Kneat Validation Platform
• Strong analytical and troubleshooting skills, and the ability to work independently while collaborating across teams

Location

Bend, Oregon, onsite. Candidates should be ready to support commissioning and validation work in an active construction and GMP manufacturing environment.