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Job Details
Job Description: GMP Technical Writer
Location: Carlsbad, CA
Industry: Pharmaceuticals
Job Summary
We are seeking an experienced GMP Technical Writer who has strong knowledge and
experience in Pharmaceutical Manufacturing. The ideal candidate will be responsible for
developing, revising, and managing GMP-compliant documentation, including Standard
Operating Procedures (SOPs), Work Instructions (WIs), Batch Records, Release
Certificates, and Compliance Documents.
This role requires expertise in pharmaceutical manufacturing documentation, with a
strong focus on Good Manufacturing Practices (GMP), regulatory compliance (FDA,
ISO), and commissioning, qualification, and validation (CQV) processes. The Technical
Writer will collaborate closely with Subject Matter Experts (SMEs), Quality Assurance
(QA) teams, engineers, and operations personnel to ensure accurate and regulatory-
compliant documentation.
Key Responsibilities
- Documentation Development & Management
Author, review, and revise GMP-compliant documentation including:
o SOPs, Work Instructions, Batch Records, Release Certificates, and Forms.
o Equipment qualification and validation documentation.
o Process and operational documentation.
Ensure documentation adheres to FDA 21 CFR Part 11, Good Documentation
Practices (GDP), and Pharmaceutical Quality Systems.
Utilize document management systems such as eSOPs, Condor, or Veeva to store
and track revisions.
Develop flow diagrams, process maps, and visual documentation to enhance
procedural clarity.
- Compliance & Regulatory Alignment
Ensure all documentation meets compliance standards.
Collaborate with QA, QC, and regulatory teams to ensure alignment with compliance
and audit requirements.
Support change control documentation and manage updates to existing SOPs and
procedures.
- Cross-Functional Collaboration & Knowledge Transfer
Work closely with SMEs, engineers, and manufacturing teams to gather detailed
process information.
Conduct interviews, research, and hands-on observations to accurately document
technical processes.
Participate in weekly project meetings (onsite or via Microsoft Teams) to align on
deliverables and progress.
Provide training materials or guidance to personnel on updated SOPs and
documentation best practices.
Qualifications & Experience
Education & Certifications:
Bachelor s or Master s degree in Technical Writing, Life Sciences, Engineering,
Pharmaceutical Sciences, or a related field.
Certifications in GMP, FDA Compliance, or Regulatory Writing (preferred).
Industry Experience:
5 years of experience in technical writing within pharmaceuticals, biotechnology, or
medical devices.
Proven experience in GMP-regulated environments and documenting SOPs for
manufacturing facilities.
Familiarity with cleanroom operations and aseptic processing (preferred).
Technical Skills & Tools:
Strong proficiency in Microsoft Office Suite (Word, Excel, Visio, PowerPoint) for
structured documentation.
Experience with document management systems (eSOPs, Condor, Veeva, or similar
CMS).
Ability to create engineering documentation, process flow diagrams, and technical
illustrations.
Regulatory & Compliance Knowledge:
In-depth understanding of FDA 21 CFR Part 11, Good Documentation Practices
(GDP), and ISO compliance.
Ability to integrate QA/QC requirements into documentation.
Key Competencies & Soft Skills
Analytical & Detail-Oriented Ability to translate complex processes into clear,
structured, and compliant documentation.
Self-Sufficient & Independent Worker Capable of managing multiple
documentation projects under tight deadlines.
Strong Communication & Collaboration Experience working with SMEs,
engineers, and QA teams to gather technical details.
Adaptability & Problem-Solving Ability to quickly grasp new processes and
adjust documentation as needed.
