Automation CSV Engineer

Automation CSV Engineer

Redmond, WA | Site Based (3 days per week onsite)

Contract-to-hire

Experience 5 Years

Work Model Site Based

ROLE OVERVIEW

We are seeking an Automation CSV Engineer to support validation, compliance, testing, and technical documentation for GMP

automation and computerized systems within a regulated manufacturing environment. The role partners closely with Automation, Quality Assurance, IT/CSV, Manufacturing, Engineering, Validation, system owners, and external service providers to ensure systems remain compliant, reliable, and in a validated state throughout their lifecycle.

KEY RESPONSIBILITIES

• Develop and support lifecycle validation strategies for GMP automation systems including Emerson DeltaV, process historians,

SCADA platforms, PLC/HMI controls, batch applications, and supporting infrastructure.

• Define validation deliverables based on intended use, system complexity, configuration, product/process impact, and risk.

• Support new system implementations, expansions, upgrades, migrations, security updates, patches, modifications, and

decommissioning activities.

• Assess automation changes for validation impact and determine required testing, documentation, approvals, and release readiness.

• Author, review, revise, and maintain validation and engineering documentation including validation plans, URS/FRS,

functional/configuration specifications, system/data flow descriptions, risk assessments, RTMs, IQ/OQ/PQ protocols, functional

test scripts, deviations, validation summary reports, SOPs, and work instructions.

• Ensure requirements are clear, testable, traceable, and appropriate for intended use; ensure executed records are complete,

accurate, attributable, and consistent with site procedures.

• Plan, coordinate, witness, or execute FAT, SAT, commissioning, qualification, regression, and automation functional testing.

• Verify automation functions such as sequences, phases, recipes, interlocks, alarms, permissives, calculations, interfaces, security roles, electronic records, and exception handling.

• Document test exceptions and unexpected results, support troubleshooting/retesting, and confirm corrective actions are complete before final acceptance.

RISK, DATA INTEGRITY & QUALITY SYSTEM SUPPORT

• Apply risk-based validation principles consistent with applicable regulations, company procedures, and recognized industry

practices.

• Support system, functional, data integrity, and validation impact assessments; scale testing rigor and documentation depth based on intended use, process criticality, system complexity, and product/patient risk.

• Evaluate GMP data flows, interfaces, calculations, records, reporting functions, audit trails, electronic signatures, access controls, account management, backup/recovery, time synchronization, and record retention.

• Support ALCOA data integrity expectations and periodic reviews used to confirm continued validated state.

• Provide automation/CSV input to change controls, deviations, CAPAs, investigations, remediation testing, effectiveness checks,

lifecycle records, audits, inspection readiness, and regulatory inspection support.

• Assess configuration, hardware, software, infrastructure, recipe, interface, and security changes for GMP and validation impact.

CROSS-FUNCTIONAL & LIFECYCLE SUPPORT

• Gather and clarify requirements with process owners, operators, engineers, technical SMEs, QA, IT/OT, Validation, Manufacturing, and system owners.

• Participate in design reviews, project meetings, change review boards, risk workshops, deviation investigations, and release

readiness discussions.

• Review vendor and system integrator documentation for technical adequacy, traceability, and suitability as validation evidence;

coordinate supplier testing where applicable.

• Support user access reviews, account recertification, backup verification, restore testing, disaster recovery activities, cybersecurity controls, system health assessments, lifecycle planning, and obsolescence evaluations.

• Develop or improve templates, test methods, procedures, and tools that increase validation efficiency without reducing assurance.

• Communicate validation status, open issues, decisions, and schedule risks to technical and business stakeholders.

REQUIRED SKILLS & EXPERIENCE

• Bachelor's degree in Engineering, Computer Science, Information Systems, Biotechnology, Life Sciences, or a related technical discipline, or equivalent education and relevant experience.

• 5 years of experience in automation validation, computer system validation, commissioning/qualification, automation engineering, or computerized system quality within a regulated environment.

• Hands-on experience with one or more industrial automation technologies such as Emerson DeltaV, AVEVA/OSIsoft PI System, SCADA, PLC/HMI systems, batch control systems, or manufacturing data collection/reporting applications.

• Experience creating and executing validation/qualification deliverables including FAT, SAT, IQ, OQ, PQ, regression testing, or automation functional testing.

• Strong technical writing skills with demonstrated experience producing clear, accurate, and defensible validation documentation.

• Working knowledge of GMP system lifecycle controls and applicable guidance including 21 CFR Part 11, EU GMP Annex 11, GAMP 5, data integrity principles, and risk-based computerized system assurance practices.

• Experience working within formal quality systems including change control, deviations, CAPAs, risk management, and investigation support.

• Understanding of automation system architecture, interfaces, configuration management, operational support, and system lifecycle controls.

• Ability to manage multiple priorities while maintaining documentation quality, schedule awareness, and strong communication with technical and nontechnical stakeholders.

GOOD TO HAVE

• Direct experience validating or supporting Emerson DeltaV in a GMP manufacturing environment, including batch configuration, phases, recipes, modules, alarms, interlocks, security, or system interfaces.

• Experience in pharmaceutical, biotechnology, biologics, cell therapy, gene therapy, or medical device manufacturing.

• Familiarity with MES, electronic batch records, process historians, laboratory systems, building automation systems, or

manufacturing data platforms.

• Experience with OPC, databases, middleware, reporting tools, industrial network infrastructure, eQMS platforms, electronic

document management systems, or electronic validation tools.

• Experience supporting GMP system upgrades, migrations, disaster recovery testing, cybersecurity remediation, supplier

documentation review, audits, inspections, or remediation programs.

• Experience working with automation system integrators, equipment vendors, validation service providers, or managed service

partners.