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Validation Technical Writer for Analytical Instruments
2 months ago
Company Overview
Veolia North America is a global frontrunner in water recovery, treatment, and reuse solutions. We engineer, supply, and maintain a diverse array of water systems and monitoring technologies across various sectors, including pharmaceuticals, food and beverage, microelectronics ultrapure water, municipal water, and industrial wastewater management. Renowned for our innovative total organic carbon (TOC) analyzers and certified reference materials, we have recently expanded our analytical instruments portfolio with a state-of-the-art endotoxin analyzer. Our commitment lies in delivering exceptional technology, design, quality, service, and application support.
Position Summary
The Validation and Data Integrity Technical Writer is responsible for the creation and refinement of installation, operational, and performance qualification validation protocols and documentation to support the Analytical Instruments' instrument and software offerings.
Key Attributes:
- Exceptional attention to detail and proofreading skills
- Collaborative team player who tackles challenges with enthusiasm
- Innovative professional who thrives in a technical setting alongside engineers
Responsibilities:
- Develop, edit, and format product and validation documentation clearly and consistently across extensive documents.
- Collaborate with software developers, chemical engineers, and product managers to gather insights and produce coherent documentation.
- Draft and document validation protocols for installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and software qualification.
- Generate validation documents to ensure compliance with 21 CFR Part 11 and best practices related to data integrity.
- Understand, operate, and evaluate analytical instruments to document customer operations, including IQ, OQ, and PQ.
- Capture and update visual content for publications, including screenshots, photographs, and protocol results.
- Coordinate reviews, revisions, and updates of product documentation to align with customer requirements and project timelines while adhering to a Configuration Management release process.
- Modify documents, parts, and printing specifications as part of the Change Order Process utilizing the SAP System.
Qualifications:
Essential:
- Proven writing and technical skills enabling independent generation of technical documentation.
- Strong collaboration and communication abilities (written, verbal, and listening).
- Excellent organizational and time-management capabilities.
- Ability to interpret technical materials and comprehend hardware functionalities while learning new software products.
- Experience in project scoping, planning, and meeting deadlines.
- Proficiency in Microsoft Word and Adobe Acrobat (for editing PDFs).
- Experience in defining and executing qualification protocols.
- Familiarity with IQ/OQ/PQ requirements and documentation.
- Understanding of data integrity and 21 CFR Part 11.
Education & Experience:
Required:
- Bachelor's degree in life sciences or engineering.
- A minimum of 3 years of experience in the life sciences or analytical instrument sector.
Preferred:
- Hands-on experience with analytical instruments, including documentation of their features and instruction creation.
- Experience working with Agile software development teams.
- Familiarity with Adobe Creative Cloud applications (InDesign, Illustrator, Photoshop).
Why Join Us?
- We value diversity and strive to create an inclusive workplace that empowers individuals to contribute their best.
- Recognition and rewards for your hard work and accomplishments.
- Opportunities for new challenges and career advancement.
- A supportive leadership team and a collaborative culture that fosters innovation.
- Commitment to recognizing talent and assisting in building sustainable careers.
At Veolia, we believe that diverse teams lead to smarter decisions, better results, and stronger communities. We are proud to be an equal opportunity employer, committed to diversity and inclusion at every level of our organization.
