Sr. Technical Writer, Manufacturing

Avid Bioservices

40d•$88,000 - $99,900•Onsite

About The Position

Avid Bioservices is seeking a Sr. Technical Writer, Manufacturing to author, revise, and maintain clear, compliant, and operator-friendly GMP documentation. This role involves working directly with Manufacturing Subject Matter Experts (SMEs) on the production floor to translate actual manufacturing practices into effective SOPs and controlled documents. The position partners closely with Quality while remaining Manufacturing-owned, ensuring documentation accurately reflects work performed across Formulation, Upstream, and Downstream operations.

Requirements

Bachelor’s degree in a scientific, engineering, or related discipline, or equivalent industry experience.
5+ years of GMP technical writing experience within biologics, pharmaceutical, or regulated manufacturing environments.
Hands-on experience authoring and revising SOPs, deviations, CAPAs, and change controls from a manufacturing perspective.
Strong understanding of biologics manufacturing operations, including Formulation, Upstream, and Downstream processes.
Proven ability to work directly with manufacturing personnel and SMEs to capture accurate process details.
Strong knowledge of FDA GMP regulations and documentation best practices.
Experience using electronic document management systems (e.g., Veeva, TrackWise).
Excellent written and verbal communication skills with a strong attention to detail.
Ability to balance compliance requirements with practical, operator-focused documentation.

Responsibilities

Author, revise, and maintain Manufacturing SOPs, work instructions, forms, and related controlled documents in alignment with GMP requirements.
Work side-by-side with Manufacturing SMEs on the floor to observe operations and accurately document process execution.
Translate real-world manufacturing practices into clear, compliant, and usable procedures that support right-first-time execution.
Support Manufacturing-owned documentation for deviations, CAPAs, and change controls, including drafting and revising manufacturing sections.
Partner with SMEs to ensure investigations, CAPAs, and Change Controls accurately reflect manufacturing execution and root cause.
Coordinate document review, approval, and revision workflows through electronic document management systems.
Ensure timely updates to GMP documentation in response to process changes, continuous improvement activities, and audit findings.
Support Manufacturing during client audits and regulatory inspections by assisting with document presentation, remediation, and follow-up updates.
Maintain document lifecycle management, including periodic review, version control, and archival in accordance with company procedures.
Manage multiple documentation projects simultaneously while meeting deadlines and manufacturing priorities.
Collaborate cross-functionally with Quality, MSAT, Engineering, and Operations to ensure documentation alignment.
Be responsive to operational needs, demonstrate strong ownership of deliverables, and provide disciplined documentation support that enables safe, compliant, and efficient manufacturing operations.