The Software Validation Engineer will be based in Kallang, Singapore. As a member of the Computer Software Validation team, this person will work in a dynamic, multi-cultural team environment and play a significant role in implementing software validation process for the software used in Flex Medical. This person provides expertise on Computer Software Validation to establish and maintain the validated state of the Corporate-wide Systems utilized on different Flex Medical Sites and will partner cross-functionally with Business, IT, Production Implementation group , and other engineering groups in the design, development, launch, and validation of new and upgrading Computer Software Systems.
We are looking for someone who demonstrates:
- Intense collaboration
- Passionate customer focus
- Thoughtful, fast, disciplined execution
- Tenacious commitment to continuous improvement
- Relentless drive to execute software validation successfully
Here is a glimpse of what you’ll do:
- Analyzes, and presents the validation strategy for software used to enhance/upgrade, business execution, production manufacturing process, concerning factors such as business situations, production capabilities, manufacturing problems, economic trends, design and development of new / upgrading software solutions
- Suggests and debates alternative methods and procedures in solving problems and meeting regulatory requirements
- Responsible to establish the CSV procedures used in projects to ensures the relevant computer systems are in compliance with applicable regulations including GAMP5, FDA Title 21 Code of Federal Regulations (CFR) Part 11, 820 and Annex 11
- Overseeing and executing the validation of new systems; evaluating and performing periodic reviews of existing validated systems and maintaining required change control procedures to ensure the state of software validation
- Communicates and reports the status of each project to the management and department
- Prepare and maintain CSV deliverables for software running in the corporate or the facility to ensure they are all adequately validated projects for used and undertaken within Flex Medical
- Educate and train the facility stakeholders about organization policy and procedures related to CSV
- Cooperates with coworkers in formulating and establishing company operating procedures and goals
- Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures
- Reviews technical publications, articles, and abstracts to stay abreast of technical developments in the industry
- Maintain a validated state under Software Validation procedures / Master Plan document as needed
- Assist with determination of root cause, impact, and resolution of problems impacting production
- May be required to travel both domestically and internationally
Here is some of what you’ll need (required):
- Degree or Master holder in Computer Science or related Engineering / Science field with multiple computer-systems programming experience
- At least 6 years of relevant experience and a Subject Matter Expert in a software CSV or GAMP guidelines implementation
- Experience in the medical device or pharmaceutical industry in product development, software validation, quality management, process controls, document controls, and continuous improvement methods
- Experienced with various IT SDLC, GAMP Software Validation.
- Provide software SDLC (Software Development Life Cycle) and validation expertise with regulatory compliance guidance and direction in order to meet with GMPs, FDA 21CFR820, FDA 21CFR11, GAMP, IEC 62304, and applicable regulations for computerized systems with the Flex Global IT as well as Flex Health Solutions organizations
- Good interdepartmental communication, influence and documentation skills are required
Here are a few of our preferred experiences:
- ASQ accreditation (CSQE, CQE or CMQ/OE).
- Experience with Microsoft Office, Microsoft Project, Visual Studio, SAP/ERP, and Manufacturing Execution Systems
- Experience working on multiple projects simultaneously
- Experience in medical device/equipment validation
- Experience in FDA Audit support/involvement
Job Category IT
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