Veolia North America
Analytical Instruments Validation Tech Writer/Engineer
Veolia North America, Boulder, Colorado, United States, 80301
Company Description Veolia Water Technologies & Solutions (VWTS) is a worldwide leader in water recovery, treatment, and reuse. We design, supply, and service a range of water systems and monitoring equipment in industries ranging from pharmaceutical to food and beverage applications, and from microelectronics ultrapure water to municipal water and industrial wastewater treatment. We are one of the world's leading manufacturers of total organic carbon (TOC) analyzers and corresponding certified reference materials. Our ground-breaking endotoxin analyzer is the latest addition to our expanding analytical instruments portfolio. We strive to provide not only superior technology and design, but also outstanding quality, service, and application support.Job Description
Job Summary
The Validation and Data Integrity Technical Writer specializes in the development and finalization of installation, operational, and performance qualification validation protocols and documentation to support the Analytical Instruments' instrument and software products.
Key Characteristics:
* Meticulous in attention to detail and proof reading skill
* Strong team player who approaches challenges with enthusiasm and energy
* Creative professional who enjoys working in a technical environment with engineersDuties & Responsibilities
* Create, edit, update, and format product and validation documentation in a clear and concise manner with appropriate detail and consistency across lengthy documents
* Acquire knowledge from software developers, chemical engineers, and product managers to develop in-depth documentation and collaborate with these team members as necessary to generate understandable and consistent materials
* Create and document validation protocols for installation qualification (IQ), operation qualification (OQ), performance qualification (PQ), and software qualification
* Create validation documents to certify 21 CFR Part 11 compliance and best practices regarding data integrity
* Understand, operate, and test analytical instruments to document customer operations including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), and software
* Create, capture, and update images for publications (screen shots, photos, protocol results, cover pages, etc)
* Coordinate product documentation reviews, revisions, and updates to meet customer
requirements and project schedules while following a Configuration Management release process
* Create and modify documents, parts, and printing specifications as part of Change Order Process using SAP SystemQualifications
Knowledge, Skills &AbilitiesRequired:
* Demonstrated writing and technical ability that allows for the independent generation of technical documentation materials
* Excellent collaboration and communication skills (written, verbal, and listening)
* Organizational and time-management skills
* Ability to interpret technical material including understanding how hardware products work and to learn new software products
* Ability to scope project, create project plan, and meet deadlines
* Microsoft Word
* Adobe Acrobat (editing pdfs)
* Experience defining and conducting qualification protocols
* Understanding of IQ/OQ/PQ requirements/protocols/documentation
* Understanding data integrity and 22 CFR Part 11
Education & Experience Required:
* Bachelor's degree in life sciences or engineering
* At least 3 years' experience working in a life science or analytical instrument industryPreferred:
* Hands-on experience working with analytical instruments and documenting their features, and creating instructions
* Experience interfacing with Agile software development teams
* Experience using Adobe Creative Cloud apps (InDesign, Illustrator, Photoshop)Additional Information
Why You'll Love Working Here!In diversity lies strength - We strive to be a workplace that is inclusive and empowers people to contribute their bestRecognition and rewards for your hard work and achievementsOpportunity for new challenges - We are growing and love to promote from withinAn excellent leadership team and a collaborative culture that values innovationAt all levels of the organization, we recognize talent and want to help you build your sustainable career!At Veolia, we realize diverse teams make smarter decisions, deliver better results, and build stronger communities. We're an organization that champions diversity and inclusion at every rung of the ladder and are proud to be an equal opportunity workplace. Because our people are our greatest assets, we also offer competitive compensation andbenefits that include:Compensation - The salary range is tied to the market for similarly benchmarked roles.The range is not an absolute, but a guide, and offers will be based on the individual candidate's knowledge, skills, experience, and market conditions, as well as internal peer equity.Depending upon all the preceding considerations for the final selected individual candidate, the offer may be lower or higher than the stated range:$74,000 - 96,000Medical, Dental, &Vision Insurance Starting Day 1!Life InsurancePaid Time OffPaid HolidaysParental Leave401(k) PlanFlexible Spending &Health Saving AccountsAD&D InsuranceDisability InsuranceTuition ReimbursementDisclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. The Company reserves the right to modify this information at any time, subject to applicable law.****Applicants are required to be eligible to lawfully work in the U.S. immediately; employer
will not sponsor applicants for U.S. work authorization (e.g. H-1B visa) for this
opportunity****As an inclusive company, Veolia is committed to diversity and gives equal consideration to all applications, without discrimination.
As an inclusive company, Veolia is committed to diversity and gives equal consideration to all applications, without discrimination.
Job Summary
The Validation and Data Integrity Technical Writer specializes in the development and finalization of installation, operational, and performance qualification validation protocols and documentation to support the Analytical Instruments' instrument and software products.
Key Characteristics:
* Meticulous in attention to detail and proof reading skill
* Strong team player who approaches challenges with enthusiasm and energy
* Creative professional who enjoys working in a technical environment with engineersDuties & Responsibilities
* Create, edit, update, and format product and validation documentation in a clear and concise manner with appropriate detail and consistency across lengthy documents
* Acquire knowledge from software developers, chemical engineers, and product managers to develop in-depth documentation and collaborate with these team members as necessary to generate understandable and consistent materials
* Create and document validation protocols for installation qualification (IQ), operation qualification (OQ), performance qualification (PQ), and software qualification
* Create validation documents to certify 21 CFR Part 11 compliance and best practices regarding data integrity
* Understand, operate, and test analytical instruments to document customer operations including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), and software
* Create, capture, and update images for publications (screen shots, photos, protocol results, cover pages, etc)
* Coordinate product documentation reviews, revisions, and updates to meet customer
requirements and project schedules while following a Configuration Management release process
* Create and modify documents, parts, and printing specifications as part of Change Order Process using SAP SystemQualifications
Knowledge, Skills &AbilitiesRequired:
* Demonstrated writing and technical ability that allows for the independent generation of technical documentation materials
* Excellent collaboration and communication skills (written, verbal, and listening)
* Organizational and time-management skills
* Ability to interpret technical material including understanding how hardware products work and to learn new software products
* Ability to scope project, create project plan, and meet deadlines
* Microsoft Word
* Adobe Acrobat (editing pdfs)
* Experience defining and conducting qualification protocols
* Understanding of IQ/OQ/PQ requirements/protocols/documentation
* Understanding data integrity and 22 CFR Part 11
Education & Experience Required:
* Bachelor's degree in life sciences or engineering
* At least 3 years' experience working in a life science or analytical instrument industryPreferred:
* Hands-on experience working with analytical instruments and documenting their features, and creating instructions
* Experience interfacing with Agile software development teams
* Experience using Adobe Creative Cloud apps (InDesign, Illustrator, Photoshop)Additional Information
Why You'll Love Working Here!In diversity lies strength - We strive to be a workplace that is inclusive and empowers people to contribute their bestRecognition and rewards for your hard work and achievementsOpportunity for new challenges - We are growing and love to promote from withinAn excellent leadership team and a collaborative culture that values innovationAt all levels of the organization, we recognize talent and want to help you build your sustainable career!At Veolia, we realize diverse teams make smarter decisions, deliver better results, and build stronger communities. We're an organization that champions diversity and inclusion at every rung of the ladder and are proud to be an equal opportunity workplace. Because our people are our greatest assets, we also offer competitive compensation andbenefits that include:Compensation - The salary range is tied to the market for similarly benchmarked roles.The range is not an absolute, but a guide, and offers will be based on the individual candidate's knowledge, skills, experience, and market conditions, as well as internal peer equity.Depending upon all the preceding considerations for the final selected individual candidate, the offer may be lower or higher than the stated range:$74,000 - 96,000Medical, Dental, &Vision Insurance Starting Day 1!Life InsurancePaid Time OffPaid HolidaysParental Leave401(k) PlanFlexible Spending &Health Saving AccountsAD&D InsuranceDisability InsuranceTuition ReimbursementDisclaimer: The salary, other compensation, and benefits information is accurate as of the date of this posting. The Company reserves the right to modify this information at any time, subject to applicable law.****Applicants are required to be eligible to lawfully work in the U.S. immediately; employer
will not sponsor applicants for U.S. work authorization (e.g. H-1B visa) for this
opportunity****As an inclusive company, Veolia is committed to diversity and gives equal consideration to all applications, without discrimination.
As an inclusive company, Veolia is committed to diversity and gives equal consideration to all applications, without discrimination.