Sr. Validation Engineer with Pharma Experience
c2c requirement
Hi ,
WE have a urgent requirement with our client . Kindly find the job description below and revert back to me with your updated resume and the following details ,
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GxP experience:
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Validation Engineer with Pharma Experience
Location: Foster City, CA (bay area locals only)
Duration: 12 months
Rate: $DOE/hr c2c all inclusive
Senior Validation Engineer will be involved in all aspects of computer systems validation and qualification activities as part of an overall Software/Product Development Lifecycle (SDLC) approach. The candidate will provide validation and compliance consulting and project support on various technology development and implementation projects, including planning, solution design, testing, and support.
Responsibilities:
- To coordinate the validation of GMP relevant computer systems in selected program, in line with internal and external, global and local guidelines and regulations
- Coordinate the validation of computer systems ensuring that appropriate actions are carried out and recorded in accordance with approved documented procedures and in compliance with regulatory requirements and Corporate Quality Standards
- Decides the minimum level of qualification and validation necessary for local systems to ensure compliance with all relevant regulations and industry guidance documents, as well as internal local and global regulations
- Ensure that the requirements for the validation of computerized systems are communicated effectively to engineering, controls, QC, IT, QA and other relevant personnel
- Developing and managing GxP system lifecycle documentation, including Validation Plans, User Requirements Specifications (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), User Acceptance testing, traceability matrix, system, Validation Reports, SOPs, Change Control Documentation, and Risk assessment reports.
- Conducting System Compliance Risk Assessment
- Managing and coordinating all aspects of the computer systems validation activities as they pertain to SDLC, including project planning, developing validation strategies, document development and document reviews
- Configuration specifications generation detailing the specific configuration of the systems / interfaces
Experience and Skills:
- Computer System Validation:
- Computer Systems Validation / QA within FDA (GxP) regulated environments, including 21 CFR Part 11 regulation
- Automated testing tools
- Validating and qualifying various IT systems used in Life Sciences environment
- Developing full validation documentation and testing protocols (IQ/OQ/PQ/UAT) within the various SDLC phasesHave excellent writing skills.
- Good Communication skills.
- Be a self-starter and be motivated to provide a solid product quality and customer experience.
- Possess effective skills for analyzing, evaluating and troubleshooting for a specific scientific / technical discipline.
- Well-developed knowledge of pharmaceutical industry standards and requirements (e.g. cGMPs, GAMP, ICH, ISPE baseline guide, ASTM E2500).
- A Bachelor’s degree in Engineering, Management, Life Sciences, or other related technical field (or equivalent military training) with five or more years of experience in pharmaceutical or other regulated industry.
Pat
Sr.Recruiter
Global Systems LLC
Office: 214-306-6701 | Fax: 214- 975-1222 | Email: p...@globalsyst.com | Web: www.globalsyst.com
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