Harba Solutions Inc. is hiring: Technical Writer in Indianapolis

This range is provided by Harba Solutions Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$65,000.00/yr - $80,000.00/yr

Direct message the job poster from Harba Solutions Inc.

Responsibilities:

• Develop, write, and revise Standard Operating Procedures (SOPs), Batch Records, Work Instructions, and Technical Reports for GMP manufacturing operations.
• Ensure all documentation complies with FDA, EU, and other regulatory requirements.
• Collaborate with Subject Matter Experts (SMEs) to translate technical processes into clear, concise, and accurate documents.
• Review and edit existing documents to improve clarity, consistency, and compliance with GMP guidelines.
• Assist in document control processes, including version control, approvals, and archival.
• Support training programs by developing training materials and ensuring documentation is user-friendly.
• Work with Quality Assurance to manage deviations, CAPAs, and change control documentation.
• Maintain an up-to-date knowledge of current industry regulations, best practices, and emerging trends in GMP documentation.

Qualifications:

• Bachelor’s degree in Technical Writing, Life Sciences, Engineering, or a related field.
• 2-5 years of experience in technical writing within a GMP-regulated pharmaceutical, biotechnology, or medical device manufacturing environment.
• Strong understanding of FDA, EU GMP, ICH, and ISO documentation requirements.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint), document management systems (e.g., Veeva, MasterControl, Documentum).
• Excellent writing, editing, and proofreading skills with a strong attention to detail.
• Ability to work collaboratively with cross-functional teams and meet deadlines in a fast-paced environment.
• Experience with process mapping, risk assessment documentation, and training material development is a plus.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Writing/Editing, Manufacturing, and Science

Industries

Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

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