Lead Validation Documentation (Contract)

ACTalent; San Diego (CA); On-site; USD 39,000 - 48,000; Full time

Job summary

Actalent is seeking a detail-oriented Validation Technical Writer to support validation, quality, and compliance initiatives within a regulated environment. You will independently gather technical information from engineering, IT, validation, and quality SMEs, transform complex discussions into clear and compliant documentation, and drive validation deliverables through approval and implementation.

In this contract role based in San Diego, CA, you will own validation documents from draft to

Qualifications

• Bachelor's degree in a scientific, engineering, information systems, technical communications, or related discipline, or equivalent industry experience.
• 2+ years of experience authoring validation documentation within a regulated industry.
• Proven experience developing validation documentation from technical discussions rather than simply processing existing drafts.
• Hands-on experience creating and maintaining User Requirements Specifications (URS).
• Experience working directly with technical SMEs and translating complex requirements into clear, compliant documentation.

Responsibilities

• Independently author, revise, and maintain validation documentation and controlled records in accordance with quality and regulatory requirements.
• Partner with Engineering, IT, Validation, Quality, and business stakeholders to gather requirements, document decisions, and capture technical information.
• Convert complex technical discussions into structured validation deliverables, including URS, Validation Protocols, Test Scripts and Test Cases, Validation Summary Reports, IQ/OQ/PQ Documentation, Qualification Records.
• Create, revise, and maintain SOPs, work instructions, and other controlled procedures.
• Manage documentation workflows within eQMS and PLM systems, ensuring proper version control, traceability, and compliance.
• Own validation documentation from initial draft through review, approval, and implementation.

Skills

Technical writing

Stakeholder collaboration

Documentation control

Attention to detail

Independent work

Education

Bachelor's degree in a scientific, engineering, information systems, technical communications, or related discipline

Tools

Arena PLM/eQMS

Agile PLM

SAP

Job description

Actalent is seeking a detail-oriented Validation Technical Writer to support validation, quality, and compliance initiatives within a regulated environment. You will independently gather technical information from engineering, IT, validation, and quality SMEs, transform complex discussions into clear and compliant documentation, and drive validation deliverables through approval and implementation.

In this contract role based in San Diego, CA, you will own validation documents from draft to