Just-Evotec Biologics

Automation CSV Engineer - Site Based, Redmond, WA

Redmond, King County

Sponsorship not specified$115k-$127kDetected 8 days ago
SparkCybersecurityAccount ManagementPLCControlsManual TestingGMPCRISPRMedical DevicesCommunicationCritical ThinkingWritingSCADA

Stay score

odds of building a lasting career here

54Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role80
Entry-level history0
PERM / green-card track0
Lottery odds (Level III)83
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~45% per draw at Level III). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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H-1B wage level

the lottery is wage-weighted — each level is one more entry

Level II · 2×
Level I$95,4101 entry
Level II$114,8992 entries
Level III$134,3683 entries
Level IV$153,8584 entries

Level III starts at $134,368 — $19,368 above the bottom of this range, and above its posted ceiling.

DOL prevailing wage, 2026-27 wage year · Industrial Engineers (17-2112) · Seattle-Tacoma-Bellevue, WA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.

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About the role

  • The Automation CSV Engineer is responsible for supporting validation, compliance, testing, and technical documentation activities for GMP automation systems within a regulated manufacturing environment.
  • This role works across Automation, Quality Assurance, IT, Manufacturing, Engineering, Validation, and external service providers.

Responsibilities

  • Develop and support lifecycle validation strategies for GMP automation systems, including DeltaV, process historians, SCADA platforms, PLC controls, batch applications, and supporting infrastructure.
  • Support new system implementations, expansions, upgrades, migrations, security updates, patches, and decommissioning activities.
  • Support the transition of new or modified systems from project delivery into site operations and ongoing system ownership.
  • Route documents through applicable document management and electronic quality management systems.

Requirements

  • At least five years of experience in automation validation, computer system validation, commissioning and qualification, automation engineering, or computerized system quality within a regulated environment.
  • Experience creating and executing validation or qualification deliverables, including FAT, SAT, IQ, OQ, PQ, regression testing, or automation functional testing.
  • Demonstrated ability to author clear, technically accurate validation documentation.
  • Knowledge of GMP system lifecycle controls and applicable requirements or guidance, including: 21 CFR Part 11EU GMP Annex 11GAMP 5Data integrity principlesRisk-based computerized system assurance practices
  • Experience working within formal quality systems, including change control, deviations, CAPAs, and risk management.
  • Strong communication skills and the ability to work effectively with both technical and nontechnical stakeholders.
  • Successful candidates will have practical experience with platforms such as Emerson DeltaV, OSIsoft PI or AVEVA PI System, SCADA, PLC-based controls, batch systems, and associated interfaces.
  • The role requires strong technical writing, disciplined documentation practices, and the ability to translate technical system behavior into clear and defensible validation evidence.

Nice to have

  • Direct experience validating or supporting Emerson DeltaV in a GMP manufacturing environment.
  • Experience with DeltaV batch configuration, phases, recipes, modules, alarms, interlocks, security, or system interfaces.
  • Experience with system integration involving OPC, databases, middleware, reporting tools, or industrial network infrastructure.
  • Experience supporting GMP system upgrades, migrations, disaster recovery testing, or cybersecurity remediation.
  • Knowledge of software development lifecycle and configuration management practices.
  • Experience reviewing vendor documentation and leveraging supplier testing or engineering records as validation evidence.
  • Previous participation in regulatory inspections, client audits, quality audits, or remediation programs.
  • Travel and Work Flexibility

Compensation

  • $115k-$127k

Company info

  • this is who we are
  • At Evotec, we believe that curiosity is the spark that drives innovation and success.
  • As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what's possible.
  • We're on a mission to create a place where curiosity isn't just encouraged-it's celebrated.
  • Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you!
  • The Role: / your challenge, …in our journey
  • This role partners closely with Automation, Quality Assurance (QA), IT CSV, Manufacturing, and Engineering teams to help ensure automation systems remain compliant, reliable, and maintained in a validated state throughout the system lifecycle.
  • Position Summary
  • The Automation CSV Engineer provides validation and compliance support for automation and computerized systems used in GMP manufacturing operations.
  • The position is responsible for developing validation strategies, preparing and executing lifecycle documentation, assessing automation changes, and helping maintain systems in a controlled and validated state.
  • The engineer will apply technical knowledge of manufacturing control systems and risk-based validation practices to support system implementations, upgrades, modifications, periodic reviews, and ongoing operations.
  • Automation System Validation
  • Define the appropriate validation deliverables based on intended use, system complexity, configuration, product or process impact, and risk.
  • Evaluate automation changes for validation impact and determine the testing, documentation, and approval requirements needed before release.
  • Help ensure validated systems remain fit for intended use throughout their operational lifecycle.
  • Lifecycle Documentation
  • Author, review, revise, and maintain validation and engineering documents, which may include: Validation plans and system validation plansUser requirements and functional requirementsFunctional and configuration specificationsSystem and data flow descriptionsRisk assessmentsRequirements traceability matricesCommissioning and qualification protocolsIQ, OQ, and PQ protocolsAutomation functional test scriptsValidation discrepancy and deviation recordsValidation summary reportsStandard operating procedures and work instructions
  • Confirm that requirements are clear, testable, traceable, and appropriate for the system's intended use.
  • Ensure executed documentation is complete, legible, attributable, technically accurate, and consistent with site procedures.
  • Work with reviewers and approvers to resolve comments efficiently while preserving technical and compliance integrity.
  • Testing and Qualification
  • Plan, coordinate, witness, or execute FAT, SAT, commissioning, qualification, regression, and functional testing for automation systems.
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