Pharmaceutical Technical Writer Job at PharmEng Nordic ApS in City of Albany

About the job Pharmaceutical Technical Writer

Technical Writer Engineering & Utilities (Pharma)

Location : Albany, NY (Hybrid One Week Onsite Per Month)

Duration : Long-Term Contract

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.

Interested? Apply now or DM for details!

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