Technical Writer

Role: Technical Writer – AWS/Azure

Location: Remote – EST Hours

Primarily Remote; Occasional NC Site Visits

Job Summary:

We are seeking an experienced Technical Writer with pharmaceutical/GxP experience to develop clear and compliant technical documentation, including SOPs, work instructions, test protocols, and design specifications.

Responsibilities:

• Create and maintain SOPs, work instructions, test protocols, and technical documents.
• Collaborate with technical leads and SMEs to gather and document requirements.
• Translate complex technical information into clear, user-friendly documentation.
• Format and finalize technical drafts provided by engineers.
• Capture information from technical sessions and convert it into formal documentation.
• Ensure documentation aligns with quality systems and GxP requirements.

Must Have:

• 5+ years of Technical Writing experience.
• Pharmaceutical/GxP industry experience.
• Knowledge of GAMP5 and 21 CFR Part 11.
• AWS experience, preferably with strong AWS exposure.
• Experience writing SOPs and work instructions.

Nice to Have:

• AWS training or certification.
• Hands-on AWS experience.
• Experience with quality systems and GMP documentation.