Technical Writer
Intellectt Inc, Indiana, PA, United States
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.
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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.
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