Validation Technical Writer 2

Validation Technical Writer

About the Role

We are seeking a detail-oriented Validation Technical Writer to support validation, quality, and compliance initiatives within a regulated environment. This position plays a critical role in developing, authoring, and maintaining validation and controlled documentation that supports product quality, regulatory compliance, and business operations. The ideal candidate is more than a document processor. You will independently gather technical information from engineering, IT, validation, and quality subject matter experts (SMEs), transform complex discussions into clear and compliant documentation, and drive validation deliverables through approval and implementation. This role offers significant ownership and visibility across cross-functional teams in a fast-paced, highly regulated environment.

Key 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: User Requirements Specifications (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.
- Support change-control initiatives by preparing document revisions, redlines, and associated documentation packages.
- 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.
- Coordinate with stakeholders to incorporate feedback while maintaining document accuracy, consistency, and integrity.
- Identify documentation gaps, project risks, and process improvement opportunities, escalating concerns when necessary.
- Ensure all documentation meets internal quality standards and is inspection- and audit-ready.
- Manage multiple documentation projects simultaneously while meeting deadlines in a dynamic environment.

Required 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)
- Validation Protocols
- Test Cases and Test Scripts
- Validation Reports
- IQ/OQ/PQ Documentation
- Qualification Documentation

- Experience working directly with technical SMEs and translating complex requirements into clear, compliant documentation.
- Strong understanding of validation methodologies and documentation practices within regulated environments.
- Experience utilizing eQMS, PLM, document control, and change-control systems.
- Excellent technical writing, editing, and communication skills.
- Strong organizational skills with exceptional attention to detail.
- Ability to manage competing priorities while maintaining quality and compliance standards.
- Self-directed professional capable of working independently with minimal supervision.

Preferred Qualifications

- Experience within the medical device, biotechnology, pharmaceutical, diagnostics, or other regulated life sciences industries.
- Familiarity with: Arena PLM/eQMS
- Agile PLM
- SAP
- Comparable quality and document-management systems

- Experience supporting Computer System Validation (CSV) and software validation projects.
- Knowledge of ISO-regulated environments, including document control and quality management practices.
- Experience supporting change-control and CAPA-related documentation activities.
- Strong problem-solving abilities and experience working across multidisciplinary teams.
- Ability to quickly learn new systems, processes, and technologies.

What Success Looks Like

Within your first 3060 days, you will:

- Become proficient in the organization's document-control and change-order processes.
- Participate in validation and technical review meetings with cross-functional stakeholders.
- Independently gather requirements and translate technical discussions into validation documentation.
- Support document revisions, SOP updates, and change-control activities.
- Build strong working relationships with Quality, Engineering, Validation, and IT teams.
- Successfully manage validation deliverables through review and approval cycles.

Why Apply?

- High-visibility role with direct interaction across Engineering, Validation, IT, and Quality teams.
- Opportunity to own critical validation and compliance documentation from concept through implementation.
- Exposure to quality systems, validation programs, and regulated product development environments.
- Collaborative culture that values technical expertise, accountability, and continuous improvement.
- Opportunity to make a measurable impact on compliance, quality, and operational excellence.

This position is ideal for a technical writer who enjoys engaging with subject matter experts, translating complex information into meaningful documentation, and taking ownership of validation deliverables in a regulated environment.
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 11, 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.