Company Description:


Westbourne IT Global Services is a transglobal organisation currently with Delivery Centres in Auckland, Cork and Foster City. Our business strategy is to significantly grow and expand our business over the next 2 - 3 years through a combination of organic growth and acquisitions. Our core differentiator is our ability to deliver scalable and world class 24*7 technical helpdesks. Our target market is a combination of Fortune 500 clients and high growth companies in the pharma, life sciences and IOT/manufacturing sectors. We have built our established reputation with an impressive list of long-standing clients because of our unique culture. This culture places innovation, problem solving, people engagement and trust at the heart of our company. Our mission is to be a global leader in innovative IT customer support solutions that meet and exceed our business partner’s requirements.


Position Overview


We are looking for a senior Labware LIMS Computer Systems Validation Engineer with GMP experience in creation, review and approval of CSV deliverables for laboratory informatics implementation projects.

 

Responsibilities:


  • Develop Validation Plans and Change Controls for Labware LIMS (Laboratory Information Management System)
  • Develop Validation testing strategy in accordance with policy and procedures
  • Working closely with System Manager, Quality Assurance and Business Process Owners to effectively and efficiently implement LIMS projects
  • Assist with understanding the business requirements, analyze and suggest technical solution for LIMS projects
  • Work closely with other validation team members to ensure system impact is assessed and mitigation strategy is in place for multiple sites using LIMS application
  • Create, review & approve CSV deliverables such as, User/Functional Specification, Design specification, IQ/OQ/PQ qualifications for LIMS projects
  • Qualification protocols execution and final report view and approval for LIMS projects
  • Partner closely with the business to ensure that CSV methodologies are well understood and applied in a manner that will procedure the most value on LIMS projects
  • Learn and become proficient with the EDMS (Electronic Data Management System), for document review and approval and ELMS (Electronic Leaning Management System) for documenting and performing assigned training.
  • Prepare, revise and obtain approval of the following documents for GMP laboratories related to the LIS systems:


1. Standard Operating Procedures (SOPs)

2.Work Instructions (WIs) Forms

3.User Manuals / User Guides / User References / Quick Reference Guides and Training Material

4. Training Plans

5. Reference Documents

6. Specifications

7. Reports



Required Experience / Skills:


  • Minimum of 3-5 years of experience working on a Labware LIMS application and GMP pharmaceutical / biotechnology / medical device environment. Laboratory experience as a chemist or microbiologist, et al is preferred.
  • Advanced knowledge and expertise Computer System Validation, FDA & international requirements and Part 11 requirements. 
  • Ability to master technical content through interaction with subject matter experts.
  • Effective communication and interpersonal skills. 
  • Computer Systems Validation (CSV) experience writing validation deliverables per GAMP guidelines is required.
  • Understanding of programming and relational database concepts is required.

 

Required Education:

  • BA/BS degree related to technical writing; e.g. biology, chemistry, computer science and/or technology disciplines is preferred.

 

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