Senior Validation Documentation Specialist

Actalent

San Diego (CA)

On-site

USD 39,000 - 48,000

Full time

2 days ago

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Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Paid time off

Onsite work in San Diego

Job summary

Actalent in San Diego, CA seeks a Validation Technical Writer to create, revise, and manage validation documentation within a regulated environment. You will work with SMEs and Quality to translate technical discussions into URS, protocols, test cases, and final reports, ensuring traceability and compliance.

This onsite contract role emphasizes owning deliverables end-to-end, managing change-control workflows in eQMS/PLM, and delivering accurate documentation on deadlines across multiple

Qualifications

Experience documenting validation deliverables in regulated environments.
Ability to turn technical discussions into URS, protocols, tests, and reports.
Familiarity with change-control workflows in eQMS/PLM systems.

Responsibilities

Develop and maintain validation documentation packages for projects.
Create URS, validation protocols, test cases, and validation reports.
Attend SME meetings, capture requirements, and translate decisions.
Translate complex discussions into clear, compliant validation docs.
Support change-order routing and eQMS/PLM workflows.
Ensure traceability and timely delivery across multiple projects.

Skills

Validation documentation

Regulated environment

Technical writing

URS & protocols

eQMS/PLM experience

Tools

Arena PLM/eQMS

Agile PLM

SAP

eQMS

Job description

This onsite contract role emphasizes owning deliverables end-to-end, managing change-control workflows in eQMS/PLM, and delivering accurate documentation on deadlines across multiple

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