Job description
Our client is a leading biopharmaceutical company based in MA. Their team is now looking for a Manufacturing Technical Writer.
Salary/Hourly Rate:
$45/hr - $50/hr
Position Overview:
The Manufacturing Technical Writer will develop update, and maintain precise, compliant, and well-structured standard operating procedures (SOPs), batch records, and technical documentation for pharmaceutical manufacturing. The Manufacturing Technical Writer ensures all materials align with Good Manufacturing Practices (GMP), regulatory standards (e.g., FDA, EMA), and internal quality requirements.
Responsibilities of the Manufacturing Technical Writer
- Write, edit, and maintain SOPs, batch records, work instructions, and other technical documents to support manufacturing operations, equipment use, and quality control processes.
- Ensure all documentation complies with GMP, EMA, FDA and other relevant regulatory standards, as well as internal policies.
- Collaborate with Subject Matter Experts (SMEs) to gather technical information and ensure accuracy in documentation
- Convert intricate technical procedures into clear, accessible guidelines that improve workflow efficiency and minimize mistakes
Required Experience/Skills:
- 2+ years of GMP technical writing experience.
- Expertise in technical writing and editing, ensuring documents are clear, precise, and concise.
- Deep knowledge of pharmaceutical manufacturing processes, equipment, and industry-specific terminology.
- Proficiency in document management platforms such as Veeva, Trackwise, MasterControl, Documentum, and Microsoft Office Suite.
- Familiarity with regulatory standards, including 21 CFR Part 211 and ICH Q7.
Preferred Experience/Skills:
- Certification in Technical writing or GMP training.
Education Requirements:
Bachelors in Technical Writing, Chemistry, Biology, Engineering or Pharmaceutical Sciences.
Benefits:
- Medical.
- Dental.
- Vision.
- Paid Holiday.
- Sick Time.
- 401k.
