Technical Writer (Part Time, Remote US Based)
Validation Technical Writer (Part-Time, Remote – U.S. Based)
About Us
We are a consulting and systems integration firm delivering innovative solutions across life sciences, power and utilities, manufacturing, and water/wastewater industries. Headquartered in Hopedale, MA, we’ve been helping global companies optimize their operations for over 20 years. As we continue to grow, we’re excited to expand our team. The Role We are seeking a detail-oriented Validation Technical Writer to join our team on a part-time basis (approximately 20 hours per week). For the right candidate, this role may grow into a full-time opportunity. Remote applicants are welcome, though residency in the United States is required. In this role, you’ll collaborate closely with engineers, project managers, and subject matter experts (SMEs) to produce high-quality documentation that meet regulatory expectations (FDA and ISO) and customer standards. You’ll play a key role in ensuring that technical information is clear, accurate, and compliant with customer and industry standards.
Key Responsibilities
- Draft, edit, and finalize validation documents including URS, FAT, SAT, IQ, and OQ.
- Generate design specifications for custom automation.
- Develop and edit WKIs, SOPs, and other miscellaneous engineering documents.
- Coordinate with SMEs and customers to define approach, scope, and technical accuracy.
- Manage document review cycles and track stakeholder feedback.
- Work with project managers to align documentation with project deliverables and schedules.
- Ensure formatting, style, and terminology are consistent across all documentation.
- Research, write, edit, and proofread technical content including manuals, specifications, training materials, and reports.
- Organize and maintain documentation libraries for ongoing and completed projects.
- Contribute to internal and external communications (such as training content, blogs, or knowledge resources).
Minimum Qualifications
- Minimum 1 year of experience in a regulated industry such as pharmaceuticals, biotechnology, or medical devices.
- Hands-on experience writing or executing validation protocols (IQ/OQ/PQ, FAT/SAT).
- Degree in engineering, life sciences, information technology, English/technical communication, or a related field OR equivalent professional experience in regulated/technical environments.
- Proven ability to work autonomously, making informed decisions using judgment, templates, and reference standards.
- Ability to apply complex formatting features (tables, styles, headers/footers, bookmarks, cross-references) to ensure documents meet regulatory and customer standards.
- Experience developing technical documentation such as SOPs, WKIs, engineering protocols, or validation deliverables, with strong writing and editing skills.
- Strong interviewing and communication skills to extract technical details from subject matter experts and translate them into clear, user-friendly documentation.
- Demonstrated ability to manage multiple projects and documentation deliverables independently, while maintaining attention to detail and compliance requirements. Desired Qualifications
- Ability to read and interpret construction documents such as P&IDs, electrical schematics, and engineering drawings.
- Working knowledge of IT/network infrastructure (switches, servers, connectivity testing) as it relates to automation and controls environments.
What We Offer
- Competitive pay.
- Flexible scheduling, Monday–Friday.
- Friendly, collaborative work environment.
- Growth opportunity into a full-time role as the company continues to expand. Job Type: Part-time (20 hrs/week) Location: Remote (U.S. only) Job Type: Part-time Pay: From $30.00 per hour Expected hours: 20 per week Benefits:
- Flexible schedule Experience:
- documentation: 1 year (Required)
- regulated industry: 1 year (Required) Work Location: Remote Apply tot his job Apply To this Job
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