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Senior CSV Lead - Syncade MES & Automation Validation
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Based on Oregon data
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What they do
A Validation Specialist tests and documents the validity and accuracy of manufacturing systems and equipment. Tests processes and manages process validations. Provides technical support and implements operating procedures. May create documentation to show that a manufacturing or production process has consistent results and meets quality standards.
$92,582 / year median in Oregon
+8% projected growth
Job Description
Senior CSV Lead - Syncade MES & Automation Validation at EFOR Senior CSV Lead - Syncade MES & Automation Validation at EFOR in Bend, Oregon Posted in 1 day ago.
Type:
full-time 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.