- Working with Waters customers from pre-sale stage to understand and clarify requirements.
- Turning customer requirements into the necessary validation deliverables.
- Performing gap analysis, developing validation plans, and managing customer expectations.
- Providing validation consultancy expert advice to customers to help guide them through the validation process.
- Assisting in the development, implementation, and maintenance of computerized systems state of validation and compliance throughout its SDLC.
- Author and/or review high-quality CSV deliverables such as Validation Plans, Test Plans and Validation Summary Reports.
- Assisting the authoring and execution of validation documents (g., System Testing, IQ, OQ, PQ, UAT) for GxP regulated computerized systems.
- Performing Data Integrity, Qualification and FDA 21 Part 11 assessments.
- Reviewing, editing, and approving validation documentation and test results.
- Assisting in computerized systems change management control and periodic review processes.
- Contributing to efforts for reaching regional financial Informatics CSV targets.
- Identifying opportunities for selling validation consulting services.
- Working with sales to develop proposals for validation services delivery which involve cost and effort estimation and scope definition (Statements of Work).
- Providing and delivering training in computer systems validation knowledge to sales and account managers.
- Collaborating with peers and external regulatory bodies on improving Waters overall compliance and CSV strategy.
- Actively following up on updates from Regulatory and Compliance organizations to best advise internal and external customers on changing trends and requirements.
- Reporting to management such issues as non-conforming products, conflicting priorities, and/or resources in meeting expected validation deliverables.
- Commitment to be a subject matter expert in at least 2 core Waters Software products.
- MSc in Computer Science, Engineering, Chemistry, or other science related field.
- In-depth knowledge of validation deliverables associated with each step of the computer system lifecycle.
- Thorough understanding of industry standards and applicable regulatory guidance and rules, e.g., 21 CFR Part 11, Annex 11, Annex 15, GxP, ISO/IEC/IEEE.
- A basic technical understanding of the overall computerized system, including networking, client/server concepts, and understanding details around the deployment of an oracle-based data acquisition system.
- Previous experience working as a billable validation consultant is desirable.
- Ability to work under pressure against tight deadlines.
- Strong interpersonal skills:
- Must possess a strong customer focus/passion.
- Demonstrates a can do attitude and presents themselves as an ambassador of Waters in the most professional way.
- Proven excellent communication skills, including in remote environment.
- Embraces training and support to facilitate continuous learning of Waters products, services, and customer satisfaction methodologies.
- Self-motivated with good organizational/time management skills and ability to work with minimum supervision.
- Language skills
- Fluent in French and English. Other EMEA languages is a valued advantage.
- Superior written and verbal communications and presentation skills for multiple audiences including users, technical team, vendors, and customer auditors.
- Software application skills
- Office 365 Suite, including MS Project, Visio.
- Empower, waters_connect and NuGenesis product knowledge is an asset.
- Knowledge of Cloud Technology (AWS, Azure, Google) a nice to have.
- Knowledge of LIMS and other laboratory platforms is an advantage.
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Senior Validation Specialist - San Antonio, United States - Waters
Description
Overview:
Reporting to the EMEA Client Services Manager, this role is part of a European team of Computer Systems Validation (CSV) specialists. You will be working closely with the overall Informatics organization to drive customer success by delivering validation services for the entire Waters informatics product line.
Combined with a solid consulting experience, this role requires a high understanding of the pharma/biopharma laboratory environment, and an understanding of how regulatory standards are applied within this industry.
As a Senior Validation Specialist for EMEA, you will be delivering billable services on client projects (onsite and remote), together with a multi-cultural team spread over a wide geography.
You may be expected to travel internationally from time to time so a valid, up to date passport, and a driving licence are necessary.
Responsibilities:75%: Providing validation consulting services and project management for Waters software products in a customer-facing capacity. This includes:
15%: Pre-sales involvement and revenue generation. This includes:
10%: Contributing to the establishment and maintenance of a CSV centre of excellence. This includes:
Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for over 60 years. With approximately 8,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.
Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. Were the problem solvers and innovators that arent afraid to take risks to transform the world of human health and well-being. Were all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.
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