Pinnaql · 20 hours ago
MV01-020626 Computer System Validation (CSV)/Technical Writer
Malvern, PA
Full-time
Onsite
Mid Level
3+ years expPinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. They are seeking a Computer System Validation Specialist/Technical Writer to support a regulated manufacturing site in Pennsylvania, responsible for executing and maintaining Computer System Validation activities to ensure compliance with FDA, GxP, and internal quality standards.
Biotechnology
Hiring Manager
Lisa Nagy SHRM-CP
Responsibilities
Execution and maintenance of Computer System Validation (CSV) activities to ensure compliance with FDA, GxP, and internal quality standards
Partner closely with Quality, IT, Engineering, and business stakeholders to develop, review, and maintain validation documentation throughout the system lifecycle
Qualification
Required
3–5+ years of experience in Computer System Validation (CSV), Quality Assurance (QA), or IT/software documentation within regulated industries (pharmaceutical, biotechnology, or medical devices)
Minimum of 3 years hands-on experience executing CSV activities
Working knowledge of FDA regulations and industry standards, including 21 CFR Part 11, EU GMP Annex 11, GxP, and GAMP 5
Strong understanding of Software Development Life Cycle (SDLC) methodologies
Knowledge of data integrity principles, Good Documentation Practices (GDP), ALCOA+ standards, electronic signatures, IT security controls, and risk-based validation approaches
Experience drafting, reviewing, and maintaining IQ/OQ/PQ protocols and validation documentation
Excellent technical writing and editing skills, with the ability to translate complex technical information into clear, concise, and audit-ready documentation
High attention to detail to ensure accuracy and compliance with regulatory standards
Ability to manage multiple projects and competing priorities in a fast-paced environment
Self-motivated, with strong organizational skills and the ability to work independently under pressure
Strong collaboration skills with the ability to work effectively in cross-functional teams
Bachelor's degree in Technical Writing, Information Technology, Life Sciences, or a related field
Company
Pinnaql
At Pinnaql we believe that different perspectives and backgrounds are what make a company flourish.
11-50 employees
H1B Sponsorship
Pinnaql 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 (1)
Funding
Current Stage
Early StageRecent News
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