Senior Validation Engineer
Posted on Aug 28, 2020 by fortice
We are heading up a project on behalf of a global IT consultancy that require a Senior Manufacturing Engineer to join their team on a major project in Cork.
What makes Cognizant a unique place to work? The combination of rapid growth and an international and innovative environment! This is creating many opportunities for people like YOU people with an entrepreneurial spirit who want to make a difference in this world.
At Cognizant, together with your colleagues from all around the world, you will collaborate on creating solutions for the world's leading companies and help them become more flexible, more innovative and successful. Moreover, this is your chance to be part of the success story: we are looking for a Validation Engineer to join our CCP-PE Team.
About Cognizant Digital Business
Cognizant delivers Product Engineering services across industry verticals in the key areas of the value chain: Conceptualization, Development, Validation, Sustenance, Value Engineering and Manufacturing support.
As a Senior Validation Engineer, you will get an opportunity to understand the client business requirements and contribute to the medical devices equipment s validation and process validation activities including,
- Develop Master Validation Plans
- Develop and complete DV/IQ/OQ/PQ protocols
- Contribute to the development of FAT/SAT protocols
- Execute Validation Protocols, root cause deviations and generate validation reports
- Liaise with approves and conduct approval meetings and documentation reviews
- Develop product specifications/drawings/quality plans in conjunction with Automated Line Project Team
- Process Risk Management/FMEA
- Provide technical expertise in CNC machining (metals & plastics)
- Troubleshoot and resolve manufacturing process issues.
- Support the Investigation of new technologies and purchase of capital equipment.
- Execute defined projects, and implement cost improvement projects.
- Lead investigation of CAPA s and product non-conformances.
- Ensure compliance with all FDA, ISO, quality, safety and environmental regulations.
- Coordinate development and validation activities for manufacturing processes.
- Develop manufacturing specifications, bills, routes and travellers in support of new and existing products and processes.
- Co-ordinate and implement process capability analysis on catheter processes
- Supervision with Project Team, Quality Engineers and Associate Engineers during project activities
- Site specific data collection across all relevant sites (Extract data from ERP systems like SAP, MES-CAMSTAR and JD Edwards)
- Experience in medical device manufacturing process, process flow and process mapping, quality system, validation and risk assessment
- Experience in technical documentation/business case/change order - writing, reviewing and routing documentation
- Experience in packaging processes and value chain analysis
- Knowledge in sterility assurance/microbiology, verification/validation, assessment of risk and mitigation plans
- Knowledge in product life cycle management, NPI/NPD, and cGxP
- Knowledge in EU-MDR, FDA CFR Title 21, ISO 13485:2016 and understanding of regulatory requirements
- Experience in formulating WBS, creation of work packets and structuring the scope at project level
Our ideal candidate (Key Skills & Experience)
Primary Skills (Must have) Experience in working statistical data analysis tools (eg Minitab) preferred
- Experience in manufacturing
- Competent in validation requirements in a regulated industry
- Experience in machine data connections
- Experience in regulated industry, ISO, FDA, AS, NADCAP etc. is preferred
- Experience in regulated industry, FDA, ISO, etc. is preferred
- Experience with CNC machining including Siemens Unigraphics NX CAM programming.
- Quality Engineering and Inspection Test Method Experience
- 6-8 years of experience in Medical Device Industry utilizing automated equipment
- Experience in statistical analysis/SPC/validation of automated equipment
- Degree in Engineering/Science Discipline and Quality Engineering Qualification
What you can expect
The Validation engineer is responsible for medical devices equipment s & process validation activities.
Apply engineering analysis and expertise to validate the mechanical, electromechanical, and/or Embedded products or systems that meets requirements and specifications and they fulfil their intended purpose. Design or plan protocols for equipment or processes to produce products meeting internal and external purity, safety and quality requirements. Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols. Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols