Validation Technical Writer

Job Title: Validation Technical Writer

Job Description

The Validation Technical Writer supports validation initiatives and the Quality team by independently developing, authoring, and maintaining validation and other controlled documentation in a regulated environment. This role requires ownership of the documentation process, from gathering technical information directly from subject matter experts to translating complex discussions into clear, accurate validation deliverables, procedural updates, and change-control records within eQMS/PLM systems.

Responsibilities

• Independently develop, author, and maintain validation documentation and controlled records, ensuring accuracy, clarity, and compliance with internal procedures and regulatory expectations.

• Attend technical meetings with engineering, IT, Quality, Validation, and other technical subject matter experts, actively participate in discussions, and capture requirements, decisions, and rationales.

• Translate SME discussions into structured validation documentation, including user requirements specifications (URS), validation protocols, test cases, validation reports, and qualification documentation such as IQ/OQ/PQ.

• Create and update procedural documentation, including SOPs and other controlled procedures, based on evolving requirements, process changes, and validation outcomes.

• Support change-order activities by preparing document revisions and redlines, and managing routing, approvals, and associated workflows within eQMS/PLM systems.

• Work within a controlled QMS/PLM environment to execute document-control and change-control processes, ensuring proper versioning, traceability, and audit readiness.

• Collaborate closely with the Quality team and technical SMEs to ensure validation documentation accurately reflects system functionality, requirements, and testing approaches.

• Own assigned validation deliverables end-to-end, from initial drafting through review cycles, incorporating feedback from multiple stakeholders while maintaining document integrity and consistency.

• Identify, communicate, and escalate roadblocks, risks to timelines, and documentation issues promptly, proposing solutions and adjustments where appropriate.

• Maintain strong attention to detail in all written materials, ensuring consistency in terminology, formatting, and structure across validation and procedural documents.

• Demonstrate organized and accountable work habits, managing multiple active documentation tasks and projects in a fast-paced environment.

• Ramp up quickly on the companys change-order and document-control processes, becoming proficient with Arena or other eQMS workflows within the first 3060 days.

• Within the first 3060 days, attend validation and technical meetings, independently capture requirements and decisions, draft validation documentation based on technical discussions, and support procedural updates and document revisions.

• Communicate proactively with the manager and stakeholders, providing regular updates on progress, risks, and questions, and ensuring deadlines are met.

• Operate independently without close day-to-day supervision, demonstrating accountability, ownership, and self-direction in managing work and deliverables.

Essential Skills

• Approximately 25+ years of relevant validation and documentation experience in a regulated environment, with demonstrated ownership of documentation rather than only processing documents created by others.

• Proven experience personally creating or substantively drafting validation documentation, including user requirements specifications (URS), validation protocols, test cases, validation reports, and IQ/OQ/PQ or similar qualification documentation.

• Direct experience attending meetings with engineering, IT, Quality, Validation, or other technical SMEs and independently converting discussions, requirements, and decisions into procedural updates, requirements, protocols, test cases, and technical/validation documentation.

• Hands-on experience working within a controlled QMS/PLM environment and understanding change-order and document-control workflows in true eQMS/PLM platforms.

• Strong understanding of validation terminology, concepts, and documentation practices in regulated industries.

• Ability to gather complex technical information from SMEs and convert it into structured, clear, and compliant documentation without requiring fully drafted inputs or detailed redlines.

• Strong written and verbal communication skills, with the ability to articulate technical information clearly and concisely to diverse stakeholders.

• High attention to detail, ensuring accuracy, completeness, and consistency in all documentation.

• Strong organizational skills and a high degree of accountability for meeting deadlines and managing multiple documentation tasks.

• Comfort incorporating feedback from multiple stakeholders and integrating comments into cohesive, high-quality documents.

• Ability to identify and escalate roadblocks and communicate risks to deadlines in a timely and constructive manner.

• Demonstrated problem-solving skills, particularly in resolving documentation issues and clarifying requirements.

• Self-directed and comfortable working independently with limited hand-holding, while proactively seeking clarification when needed.

• Ability to ramp quickly on new systems, processes, and workflows, particularly within eQMS/PLM and change-control environments.

Additional Skills & Qualifications

• Previous validation documentation experience in a regulated industry, such as medical devices or broader regulated life sciences sectors.

• Experience with eQMS or PLM systems, with exposure to platforms such as Arena PLM/eQMS, Agile PLM, or other comparable eQMS/PLM solutions.

• Familiarity with SAP as a supporting system within a broader quality and validation environment.

• Exposure to computer system validation (CSV), software validation, and ISO-related practices, which is considered a strong plus.

• Experience working on change-control and document-control processes in quality systems environments.

• Comfort working directly with Quality teams and technical SMEs on active validation initiatives and quality systems projects.

• Ability to work effectively in a fast-paced environment with multiple active projects and evolving priorities.

• Medical device industry experience preferred, with openness to candidates from other regulated life sciences backgrounds.

Job Type & Location

This is a Contract position based out of San Diego, CA.

Pay and Benefits

The pay range for this position is $28.00 - $35.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract position based out of San Diego, CA.

Application Deadline

This position is anticipated to close on Nov 16, 2026.

Workplace Type

This is a fully onsite position in San Diego,CA.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.