Technical Writer

Job Title: Validation Technical WriterJob DescriptionThe Validation Technical Writer supports a defined validation initiative and the Quality team by creating, revising, and managing technical and quality documentation within a regulated environment. This role attends validation meetings with technical subject matter experts, captures technical requirements and discussions, and independently translates that information into accurate validation documentation, including user requirements, protocols, test cases, and final reports. The position also manages change-order routing and document revisions through eQMS/PLM workflows, acting as a documentation bridge between technical teams and Quality while owning assigned deliverables from start to finish.

Responsibilities

• Develop and maintain comprehensive validation documentation packages for assigned projects.
• Create and update User Requirements Specifications (URS), validation protocols, test cases derived from requirements, and validation reports.
• Attend meetings with technical subject matter experts, actively participate in discussions, and capture relevant technical requirements and decisions.
• Translate complex technical discussions into clear, structured, and accurate validation documents suitable for a regulated environment.
• Support Quality by managing change-order routing and change-control workflows in eQMS/PLM systems.
• Refine document redlines and revisions to ensure clarity, consistency, and compliance with quality standards.
• Incorporate feedback from multiple stakeholders into documentation while maintaining document integrity and traceability.
• Act as a documentation bridge between technical SMEs and Quality, ensuring alignment on requirements, scope, and validation approach.
• Manage documentation workflows, track progress, and meet deadlines across multiple active projects.
• Proactively communicate roadblocks, risks, and potential impacts to timelines to the appropriate stakeholders.
• Independently own assigned documentation deliverables from initiation through approval, with minimal supervision.
• Ensure documentation adheres to applicable standards, including internal quality procedures and relevant regulatory expectations.
• Use eQMS/PLM tools to process documentation through appropriate approval workflows and maintain accurate document histories.
• Ask clarifying questions during technical discussions to ensure complete and accurate capture of requirements.
• Support continuous improvement of documentation templates and processes where appropriate.

Essential Skills

• Previous experience developing validation documentation within a regulated industry.
• Strong understanding of the validation lifecycle, validation terminology, and validation documentation requirements.
• Hands-on experience working within an electronic Quality Management System (eQMS) or Product Lifecycle Management (PLM) system for document revisions and change-order routing.
• Ability to create User Requirements Specifications (URS), validation protocols, test cases based on requirements, and validation reports.
• Demonstrated technical comprehension to understand discussions with subject matter experts, ask relevant questions, and capture accurate requirements.
• Proven technical writing skills with the ability to translate complex technical information into clear, concise, and structured documentation.
• Experience working with electronic systems such as eQMS, PLM, and eDHR.
• Strong written and verbal communication skills.
• High attention to detail and commitment to documentation accuracy and completeness.
• Strong organizational skills and accountability for meeting deadlines.
• Ability to incorporate feedback from multiple stakeholders and revise documents accordingly.
• Capability to identify and escalate roadblocks and communicate risks to deadlines in a timely manner.
• Strong problem-solving skills and sound judgment in a regulated environment.
• Self-directed and comfortable working independently with limited hand-holding.
• Ability to ramp up quickly on new systems, processes, and technical topics.

Additional Skills & Qualifications

• Experience with Arena PLM/eQMS is strongly preferred.
• Experience with Agile PLM is a strong comparable alternative.
• Experience with SAP is helpful in addition to core eQMS/PLM experience.
• Familiarity with ISO-related quality and documentation standards.
• Medical device industry experience is preferred.
• Broader regulated life sciences experience, such as pharmaceuticals or biotechnology, is also suitable.
• Comfort working in a fast-paced environment with multiple active projects and high expectations for quality and delivery.
• Ability to work effectively with cross-functional teams, including technical SMEs and Quality personnel.
• Comfortable taking ownership of meaningful validation deliverables rather than performing basic document routing.

Work EnvironmentThis role is fully onsite, working standard daytime hours (approximately 8:00 a.m. to 5:00 p.m.) in a fast-paced environment with multiple active validation and Quality projects. The position primarily supports a defined validation project and the Quality team, with high expectations around documentation quality, accuracy, and on-time delivery. The manager sets clear expectations and goals upfront and typically conducts weekly check-ins, but does not micromanage, so the individual must be comfortable operating independently and taking ownership of their work. The culture emphasizes accountability, proactive communication, and timely escalation of issues rather than allowing deadlines to slip. Work is performed using electronic quality and product lifecycle systems, including eQMS and PLM tools, and involves close collaboration with technical SMEs and Quality. Onsite presence is expected, and the environment values individuals who ask questions, seek clarity, and actively drive their deliverables to completion. Job Type & LocationThis is a Contract position based out of San Diego, CA. Pay and BenefitsThe 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 & LocationThis is a Contract position based out of San Diego, CA. Application DeadlineThis position is anticipated to close on Nov 16, 2026. Workplace TypeThis 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 actalentaccommodation@actalentservices.com for other accommodation options.

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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.

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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.

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