Technical Writer

PharmEng Technology; Indianapolis (IN); On-site; USD 60,000 - 95,000; Full time

Job summary

An established industry player in pharmaceutical manufacturing is looking for a detail-oriented Technical Writer. This full-time, onsite role is crucial for ensuring regulatory compliance through precise technical documentation. You will write and edit high-quality documents, collaborate with cross-functional teams, and support audit readiness. If you have a strong background in technical writing and a passion for quality operations, this opportunity offers a dynamic environment where your contributions will significantly impact the organization.

Qualifications

• 5+ years of experience in technical writing in the pharmaceutical industry.
• Strong knowledge of GMP and deviation management processes.

Responsibilities

• Write and review technical documents for compliance with FDA and GMP guidelines.
• Collaborate with teams to gather accurate information for documentation.

Skills

Technical Writing

GMP Knowledge

Deviation Management

Change Control Processes

Communication Skills

Education

Bachelor's degree in Life Sciences

Bachelor's degree in Engineering

Tools

Microsoft Office Suite

TrackWise

Job description

Join to apply for the Technical Writer role at PharmEng Technology.

Get AI-powered advice on this job and more exclusive features.

About The Job: Technical Writer

Our client, a pharmaceutical manufacturing company, is seeking a detail-oriented Technical Writer with expertise in deviations and change control documentation. This onsite role plays a critical part in ensuring regulatory compliance and supporting quality operations through precise, timely, and accurate technical documentation.

Key Responsibilities

• Write, edit, and review high-quality technical documents including deviations, change controls, CAPAs, and other GMP-related records.
• Collaborate with cross-functional teams (QA, Manufacturing, Engineering, etc.) to gather accurate and complete information.
• Ensure all documentation complies with FDA, EU, and internal GMP guidelines.
• Translate complex technical information into clear, concise, and well-structured documents.
• Assist in audit readiness by maintaining organized, traceable documentation.
• Support investigations and root cause analyses by drafting clear summaries and conclusions.

Qualifications

• Bachelors degree in Life Sciences, Engineering, or a related field.
• 5+ years of experience in technical writing within the pharmaceutical or biotech industry.
• Strong knowledge of GMP, deviation management, and change control processes.
• Excellent writing, editing, and communication skills.
• Proficient with Microsoft Office Suite; experience with TrackWise or other QMS platforms a plus.
• Detail-oriented, organized, and able to manage multiple priorities in a fast-paced environment.

Applicants must be authorized to work in the United States. Sponsorship is not available for this position.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Marketing, Public Relations, and Writing/Editing
• Industries: Pharmaceutical Manufacturing