Technical Writer

PharmEng Nordic ApS; Indianapolis (IN); On-site; USD 65,000 - 95,000; Full time

Job summary

An established industry player in pharmaceuticals is seeking a detail-oriented Technical Writer. This onsite role is pivotal in ensuring regulatory compliance and supporting quality operations through precise technical documentation. You will be responsible for creating high-quality documents related to deviations and change controls while collaborating with various teams to ensure accuracy. If you have a strong background in technical writing and a passion for the pharmaceutical industry, this is an exciting opportunity to make a significant impact in a fast-paced environment.

Qualifications

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

Responsibilities

• Write and review technical documents including deviations and change controls.
• Collaborate with cross-functional teams to gather accurate information.

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

Technical Writer Deviations & Change Control

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.