Technical Writer

Intellectt Inc; Indiana (PA); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading regulated manufacturing firm in Indiana is seeking a detail-oriented Technical Writer to support the creation and management of controlled documentation within a regulated environment. The ideal candidate will have over 3 years of experience in technical writing and must be proficient in electronic document management systems like Veeva Vault. Key responsibilities include developing SOPs, collaborating with cross-functional teams, and ensuring compliance with regulatory standards.

Qualifications

• 3+ years of technical writing experience in a regulated environment.
• Hands-on experience with electronic document management systems (eDMS).
• Experience developing controlled documentation like SOPs and training materials.

Responsibilities

• Develop, revise, and format Standard Operating Procedures (SOPs).
• Collaborate with cross-functional teams to gather technical content.
• Ensure documentation complies with regulatory requirements.

Skills

Attention to detail

Excellent written communication

Excellent verbal communication

Experience with electronic document management systems

Education

Bachelor’s degree in Engineering, Life Sciences, Technical Communication, or related field

Tools

Veeva Vault

Job description

We are seeking a detail-oriented Technical Writer to support the creation and management of controlled documentation within a regulated manufacturing environment. This role will focus on developing and revising standard documents related to device and packaging processes, engineering documentation, maintenance procedures, and training materials.

The ideal candidate will have experience working in regulated industries (medical device, pharmaceutical, or similar) and be proficient in electronic document management systems, particularly cloud-based validation lifecycle management tools.

Key Responsibilities

• Develop, revise, and format Standard Operating Procedures (SOPs), work instructions, and controlled documentation.
• Create and maintain documentation related to:
• Device manufacturing processes
• Packaging operations
• Maintenance procedures
• Training materials
• Collaborate with cross-functional teams including Engineering, Quality, Manufacturing, and Maintenance to gather technical content.
• Ensure documentation complies with internal quality standards and regulatory requirements.
• Manage document workflows, including drafting, routing for review, incorporating feedback, and final approvals.
• Utilize Veeva Vault (web-based electronic validation lifecycle management application) for document development, review, approval, and lifecycle management.
• Support project timelines by delivering documentation per established project plans.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Technical Communication, or related field (or equivalent experience).
• 3+ years of technical writing experience in a regulated environment (medical device, pharmaceutical, biotech, or similar).
• Experience developing controlled documentation (SOPs, validation documents, engineering documents, training materials).
• Hands‑on experience with electronic document management systems (eDMS).
• Experience using Veeva Vault preferred.
• Strong attention to detail and ability to manage multiple documents simultaneously.
• Excellent written and verbal communication skills.

Preferred Qualifications

• Familiarity with validation documentation (IQ/OQ/PQ).
• Understanding of GMP and quality system requirements.
• Experience supporting engineering or manufacturing environments.