Waters Corporation

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Quality Engineer - CSV temp

Quality Engineer - CSV temp

System ID 
8147
Company Name 
Waters Division
Category 
Quality Assurance
Job Locations 
UK-Cheshire-Wilmslow
Employment Type 
Temporary Full-Time
Job Location : Country (Full Name) 
United Kingdom

More information about this job

Company Description

For over 50 years, Waters Corporation has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance. Specifically, the company designs, manufactures, sells, and services high performance liquid chromatography, ultra performance liquid chromatography, and mass spectrometry technology systems and support products primarily in the United States, Europe, Japan, and Asia. Our innovations enable significant advancements within the pharmaceutical, life science, biochemical, industrial, food safety, environmental, academic and government industries. Waters is a publicly traded corporation (NYSE:WAT) with more than 6,500 employees and is represented in more than 100 countries around the world.

 

 

 

Waters Wilmslow site is the largest site globally committed to the support and development of Mass Spectrometry systems. This fantastic site is designed to create and support connectivity and efficiency by enabling us to embrace more collaborative ways of working and focus more on customer needs, quality and continual improvement in the way we innovate and design our products and systems.  This site not only brings advantages that benefit our own employees, but also provides a high-tech center for customers. 

 

A custom built Center of Excellence

Driving innovation in the birthplace of Mass Spectrometry
State of the art customer demonstration laboratories
Investing in world changing research development and manufacturing
Science in harmony with a sustainable world

Overview

Waters Corporation is currently seeking a Quality Engineer with Computer System Validation experience to join our company on a temporary basis with potential for permanent contract.  Based at our state of the art facility in Wilmslow, this new position is a key role and provides an exciting opportunity to gain experience within a global organisation in support of ongoing compliance odf the company's Mass Spectrometry and software products.

 

The successful candidate will provide support to a rapidly expanding validation team, working on projects designed to increase the standards of CSV across the site. The projects include the review and assessment of software tools used on-site with the aim of identifying and supporting any resulting validation activity plus support of the development and deployment of a new CSV process. The role requires a high degree of cross-functional collaboration whilst remaining compliant with the necessary quality standards and processes. 

 

This is an ideal role for an individual who has practical CSV experience in a regulated environment and a real passion to drive business process change as Waters adopts new product stratedgy. The individual will drive the deliverables on the Master Validation Plan and subsequent Quality Plans to ensure the quality of Waters product portfolio. 

Responsibilities

  • Act a Wilmslow site subject matter expert (SME) for Computer System Validaton (CSV) to assist the Waters Wilmslow business with instruction and training on the CSV procedure.
  • Facilitate the execution of CSV deliverables in line with the Master Validation Plan and review and approve CSV deliverables.
  • Produce updates on Master Validation Plan activities.
  • Liaise with global CSV SMEs and relevant global stakeholders to maintain or improve the Waters CSV approach ensuring best practice is applied and there is continued regulatory compliance.

Qualifications

 

  • A qualification in an Engineering/Science subject to Degree or HND level OR proven relevant experience in an Engineering/Science related function OR significant proven experience within a relevant regulated environment.
  • Proven knowledge of ISO 9001, experience in ISO 13485 and 21 CFR 820/11 and software validation methodologies (e.g. GAMP).
  • Proven experience of computer system validation within a regulated environment.
  • Understanding of software development methodologies (Waterfall, Agile)
  • Good written and oral communication skills are required for example to ensure succinct report generation, effective communication with staff and peer groups across the organisation.
  • Must be able to work independentally and communicate with all levels of the organisation.
  • Computer literate, preferably with knowledge of software packages such as Word, Excel to for example produce letters, management reports, analyse data, etc