MV01-020626 Computer System Validation (CSV)/Technical Writer

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking a Computer System Validation Specialist/Technical Writer to support a regulated manufacturing site in Pennsylvania. This role is responsible for the execution and maintenance of Computer System Validation (CSV) activities to ensure compliance with FDA, GxP, and internal quality standards. The Validation Specialist will partner closely with Quality, IT, Engineering, and business stakeholders to develop, review, and maintain validation documentation throughout the system lifecycle. The ideal candidate brings strong technical writing skills, a solid understanding of regulated environments (pharmaceutical, biotech, or medical device), and a detail-oriented approach to producing clear, audit-ready documentation that supports patient safety, product quality, and data integrity.

Qualifications

Experience

• 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.

Regulatory Knowledge (FDA / GxP)

• Working knowledge of FDA regulations and industry standards, including 21 CFR Part 11, EU GMP Annex 11, GxP, and GAMP 5.

Technical Skills

• 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.

Soft Skills

• 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.

Education

• Bachelor’s degree in Technical Writing, Information Technology, Life Sciences, or a related field

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

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