Technical Writer, Instrument Validation

Technical Writer, Instrument Validation

Work Location: Wake County, North Carolina

Summary:

Seeking a Technical Writer with expertise in instrument qualification and validation documentation. This position focuses on regulated documentation and laboratory systems, ideal for candidates who understand the importance and reasoning behind compliance paperwork.

Responsibilities:

• Prepare and maintain controlled documents such as standard operating procedures, work instructions, and forms in compliance with cGMP standards.
• Develop and update qualification deliverables, including user requirements specifications, design intent agreements, and system risk assessments.
• Create validation plans, summary reports, and qualification protocols to support laboratory instrument validation.
• Configure and manage user rights and access controls within laboratory or quality management systems.
• Collaborate with quality assurance, IT, and laboratory teams to ensure documentation aligns with system functionality and regulatory standards.
• Oversee the document lifecycle from creation through review, approval, and archival processes.
• Ensure all documentation meets regulatory requirements and accurately reflects laboratory practices.
• Support continuous improvement initiatives related to documentation and validation processes.

Qualifications:

• Minimum 3 years of technical writing experience in a GxP-regulated environment.
• Direct experience authoring validation and qualification documentation, including URS, DIAs, SRAs, and validation plans.
• Familiarity with laboratory instrument qualification processes (IQ/OQ/PQ).
• Working knowledge of document control systems and user access/rights configuration.
• Strong understanding of regulatory frameworks such as FDA 21 CFR Part 11, EU Annex 11, and USP .
• Exceptional written communication skills and attention to detail.
• Ability to work independently and manage multiple document deliverables simultaneously.
• Experience with LIMS, ELN, or chromatography data systems (e.g., Empower, Chromeleon) is a plus.
• Background in analytical chemistry or laboratory operations is advantageous.
• Prior experience at a contract research or testing laboratory is beneficial.

Published Category: Quality & Validation