Specialist 3, Technical Writing

Job Title: Technical Writer

Location: Fort Washington, PA 19034 (Hybrid)

Duration: 12+ months on W2 contract

Hours: Monday to Friday 8:30am to 5:00pm

Job description:

We are seeking a detail-oriented Technical Writer to support the development, revision, and management of manufacturing and engineering documentation within a GMP-regulated environment. This role will be responsible for converting complex engineering, validation, and technical documents into clear, compliant, and user-friendly Standard Operating Procedures (SOPs) and other controlled documentation.

The ideal candidate will have experience working in a regulated pharmaceutical, medical device, consumer health, or life sciences environment and possess strong document management skills using Microsoft Word and Adobe Acrobat. This position requires a significant on-site presence initially to build relationships with stakeholders, facilitate document reviews, and drive approvals and signatures through completion.

Key Responsibilities

• Review and interpret engineering, technical, validation, and operational documents.
• Transform technical content into clear, concise, and compliant SOPs, work instructions, and controlled documents.
• Collaborate with engineers, quality, validation, manufacturing, and cross-functional teams to gather and verify technical information.
• Ensure documentation aligns with GMP requirements, company standards, and document control procedures.
• Manage document review cycles, incorporating stakeholder feedback and maintaining version control.
• Coordinate approval workflows and actively facilitate the collection of required signatures and approvals.
• Maintain documentation accuracy, consistency, formatting, and traceability.
• Utilize Microsoft Word to develop and format professional documentation templates and final deliverables.
• Use Adobe Acrobat to review, edit, compile, and manage controlled PDF documentation.
• Support document archival, revision management, and document management system activities as required.
• Identify opportunities to improve documentation processes and standardization.

Timing and Duration

The Technical Writer is needed to start immediately to become familiar with the site''s equipment, systems, processes, and key stakeholders. The anticipated assignment duration is October 1, 2026 through October 1, 2027. Workload demand is expected to be highest during project initiation and throughout Q1 2027, as a significant volume of engineering and operational documentation will require conversion into SOPs and controlled documents. Following this peak period, the workload is expected to gradually decrease, transitioning to a part-time level of support for the remainder of the engagement while document updates, reviews, approvals, and finalization activities are completed.

Required Qualifications

• Bachelor''s degree in Technical Writing, English, Communications, Engineering, Life Sciences, or a related field, or equivalent experience.
• 2-4 years of technical writing experience in a GMP-regulated environment.
• Experience creating and editing SOPs, work instructions, controlled documents, or quality system documentation.
• Proficiency in Microsoft Word, including advanced formatting, styles, templates, tables, and document controls.
• Proficiency in Adobe Acrobat for document editing, review, and PDF management.
• Strong attention to detail with excellent proofreading and editing capabilities.
• Ability to interpret technical and engineering information and translate it into end-user documentation.
• Strong organizational, communication, and stakeholder management skills.

Preferred Qualifications

• Experience supporting pharmaceutical, consumer health, biotechnology, medical device, or manufacturing operations.
• Familiarity with document management systems and controlled document workflows.
• Experience working with Quality, Validation, Engineering, or Manufacturing teams.
• Knowledge of GMP documentation practices, data integrity principles, and compliance requirements.

Work Arrangement

• On-site in Fort Washington, PA during onboarding and initial engagement period to support stakeholder collaboration, document reviews, approvals, and signature collection.
• Opportunity for a hybrid schedule (1-2 remote days per week) once the individual has established working relationships, gained familiarity with documentation processes, and can operate independently.

Key Success Factors

• Ability to rapidly understand technical and engineering content.
• Strong ownership of documentation deliverables from draft through approval.
• Excellent collaboration skills and ability to drive documents to completion.
• Commitment to quality, compliance, and continuous improvement.

This role is ideal for a technical writer who enjoys partnering closely with engineering and quality teams to ensure critical GMP documentation is accurate, compliant, and ready for execution.

Contact:

Sharath Babu: sharath.b@sunrisesys.com | (732) 395-4575 | URL: www.sunrisesys.com