Technical Writer

Job Description

Job Summary:

• 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.

Duties & 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.

Knowledge Skills Ability:

• 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 Products partnering closely with engineering and quality teams to ensure critical GMP documentation is accurate, compliant, and ready for execution.