We are seeking a Technical Writer with experience in engineering documentation for a pharmaceutical manufacturing environment, with a strong focus on utilities and facility systems. The ideal candidate will have expertise in developing, reviewing, and managing technical documents while ensuring compliance with GMP and regulatory standards. This hybrid role requires one week onsite per month to collaborate with stakeholders and gather critical technical information.

Key Responsibilities:

Documentation Development: Create, update, and maintain SOPs, technical manuals, work instructions, and engineering documentation related to utilities (HVAC, WFI, compressed air, purified water, clean steam, etc.)
Collaboration & Content Gathering: Work closely with engineering, facilities, validation, and quality teams to collect and document technical requirements
Regulatory Compliance: Ensure all documentation meets FDA, cGMP, and industry standards
Document Workflow Management: Utilize electronic document management systems (EDMS) such as Veeva Vault, MasterControl, Documentum, or OpenText to manage approval workflows
Process Improvement: Assist in standardizing documentation processes, version control, and ensuring consistency across engineering records
Technical Editing & Formatting: Review technical content for clarity, accuracy, and compliance with company style guides

Qualifications & Experience:

Experience: 3+ years as a Technical Writer in a pharmaceutical, biotech, or regulated manufacturing setting
Technical Knowledge: Experience documenting engineering processes, utilities, and facility systems
Software & Workflow Management: Proficiency in EDMS platforms such as Veeva Vault, MasterControl, Documentum, OpenText, or similar
Regulatory & Compliance: Familiarity with GMP, FDA 21 CFR Part 11, and industry best practices
Skills: Strong attention to detail, ability to interpret technical concepts, excellent communication, and organizational skills

This is a long-term hybrid opportunity to work in a cutting-edge pharmaceutical manufacturing environment, contributing to critical engineering and utility documentation.