Manufacturing Technical Procedure Writer

The Manufacturing Technical Procedure Writer is responsible for drafting, revising, and maintaining accurate, clear, and compliant manufacturing documentation including SOPs, batch records, and work instructions. This individual plays a key role in ensuring that all documentation supports efficient operations and complies with current Good Manufacturing Practices (GMP), FDA/EMA regulations, and internal quality standards. The role supports increased workflow and backfills internal resources being reassigned to other projects.

Key Responsibilities:

• Documentation Development: Create, revise, and maintain SOPs, batch records, job aids, and other technical manufacturing documentation.
• Compliance Assurance: Ensure documentation aligns with GMP, FDA, EMA, ICH Q7, and internal requirements.
• Collaborate with SMEs: Work cross-functionally with Manufacturing, QA, Validation, Engineering, and EHS to gather accurate technical content.
• Document Control: Use electronic document management systems (EDMS) such as Veeva, TrackWise, or MasterControl to manage document lifecycle (creation, review, approval, version control).
• Audit Support: Ensure documentation is accurate and ready for internal and external inspections or audits.
• Process Optimization: Translate complex technical content into clear, user-friendly instructions; contribute to continuous improvement of documentation standards.
• Workflow: Manage 1015 documents monthly, efficiently progressing them through review and approval cycles.
• Training Support: Assist in developing training materials aligned with updated procedures.

Skills and Competencies:

• Exceptional technical writing and editing skills able to write clearly and precisely for high-risk procedures.
• Strong organizational and time-management skills with the ability to prioritize multiple projects.
• High attention to detail and commitment to documentation quality and compliance.
• Excellent interpersonal and communication skills; collaborative team player.
• Familiarity with regulatory standards such as 21 CFR Part 211 and ICH Q7.
• Ability to simplify complex concepts for non-expert users.
• Problem-solving mindset and continuous improvement orientation.

Requirements

Education:

• Bachelor's degree required (Technical Writing, Life Sciences, Engineering, or related field).

Experience:

• Junior Level:25 years of experience in technical writing within a GMP-regulated manufacturing environment.
• Senior Level:57+ years of experience with a strong record of independently managing documentation projects.

Preferred Certifications:

• Certification in Technical Writing (e.g., AMWA, STC) or formal GMP training is a plus.

Preferred Experience:

• Technical writing for high-risk or hazardous manufacturing processes.
• Strong understanding of pharmaceutical manufacturing workflows and terminology.
• Experience with EDMS tools such as Veeva, Documentum, TrackWise, or MasterControl.
• Prior experience writing and managing SOPs, batch records, and equipment-related instructions.

Benefits

• Administrative shift
• 6-months contract with possible extension