Validation Documentation Specialist

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

Job summary

Actalent in San Diego, CA, seeks a Validation Technical Writer to own the documentation lifecycle for regulated validation efforts. You will author, maintain, and control URS, IQ/OQ/PQ, validation reports, and related records in a compliant environment.

Collaborate with engineering, IT, Quality and SMEs to translate technical discussions into clear, audit-ready documents within Arena PLM/eQMS or similar systems, manage change-control, versioning, and maintain accuracy under a contract onsite

Qualifications

• 25+ years of validation and documentation experience in regulated environments.
• Hands-on creation of URS, IQ/OQ/PQ, validation reports, and related documents.
• Experience attending meetings with engineering, IT, Quality and SMEs and capturing requirements.
• Experience with eQMS/PLM platforms and change-control workflows.
• Strong understanding of validation concepts and regulatory documentation practices.

Responsibilities

• Develop, author, and maintain validation documentation and change-control records.
• Attend technical meetings and capture decisions and rationales.
• Translate SME discussions into validated documentation including URS and test cases.
• Create and update SOPs and controlled procedures.
• Manage document revisions, routing, approvals in eQMS/PLM.
• Ensure versioning, traceability and audit readiness in QMS/PLM.

Skills

Validation documentation ownership

URS/IQ/OQ/PQ drafting

eQMS/PLM experience

Regulatory/compliance knowledge

Cross-functional collaboration

Tools

Arena PLM/eQMS

SAP (QA context)

Job description

Actalent in San Diego, CA, seeks a Validation Technical Writer to own the documentation lifecycle for regulated validation efforts. You will author, maintain, and control URS, IQ/OQ/PQ, validation reports, and related records in a compliant environment.

Collaborate with engineering, IT, Quality and SMEs to translate technical discussions into clear, audit-ready documents within Arena PLM/eQMS or similar systems, manage change-control, versioning, and maintain accuracy under a contract onsite