Pharmaceutical Technical Writer jobs in United States
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PharmEng Technology ยท 5 months ago

Pharmaceutical Technical Writer

positionAlbany, New York, United States
timeFull-time
remoteHybrid
seniorityMid Level
date3+ years exp

PharmEng Technology is a company focused on engineering documentation in the pharmaceutical sector. They are seeking a Technical Writer with experience in developing and managing technical documents in compliance with GMP and regulatory standards, specifically in a pharmaceutical manufacturing environment.

ConsultingInformation TechnologyPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

Create, update, and maintain SOPs, technical manuals, work instructions, and engineering documentation related to utilities (HVAC, WFI, compressed air, purified water, clean steam, etc.)
Work closely with engineering, facilities, validation, and quality teams to collect and document technical requirements
Ensure all documentation meets FDA, cGMP, and industry standards
Utilize electronic document management systems (EDMS) such as Veeva Vault, MasterControl, Documentum, or OpenText to manage approval workflows
Assist in standardizing documentation processes, version control, and ensuring consistency across engineering records
Review technical content for clarity, accuracy, and compliance with company style guides

Qualification

GMP ComplianceEDMS ProficiencyTechnical WritingEngineering DocumentationRegulatory KnowledgeAttention to DetailCommunication SkillsOrganizational Skills

Required

3+ years as a Technical Writer in a pharmaceutical, biotech, or regulated manufacturing setting
Experience documenting engineering processes, utilities, and facility systems
Proficiency in EDMS platforms such as Veeva Vault, MasterControl, Documentum, OpenText, or similar
Familiarity with GMP, FDA 21 CFR Part 11, and industry best practices
Strong attention to detail, ability to interpret technical concepts, excellent communication, and organizational skills

Company

PharmEng Technology

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PharmEng Technology is a pharmaceutical company that provides consultancy services.
dateFounded in 1997
location
Toronto, Ontario, CAN
people-size201-500 employees
web-link
http://pharmeng.com

H1B Sponsorship

PharmEng Technology has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2022 (1)

Funding

Current Stage
Growth Stage

Leadership Team

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Alan Kwong
Managing Director & CEO
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Company data provided by crunchbase