All,
If you're interested, and qualified (must have validation experience working in a GxP environment, 21 CFR Part 11, etc.) please let me know. I can get your resume to the hiring manager.
Good luck.
Bob
Validation Engineer - Basking Ridge, NJ-333364
Description
Position Description:
The person in this position will be responsible for all validation activities for both in-house grown products development and third party product upgrade/implementation projects. Working closely with Project Managers, ensuring that assigned projects move effectively, aligned with SDLC methodologies. Need to be detail oriented and proactive to ensure all expected deliverables being assigned to proper authors, being generated following the SOP and/or Working practice, being reviewed and approved in timely manner. Validation engineer owns the full cycle of deliverables. In addition, analytical and technical enough to quickly learn system applications features to determine the depth of validation and the need of revalidation for any changes to systems, working closely with Product Management, QC team and Business Unit User group.
Primary Responsibilities:
Create and maintain validation documentation for assigned products/projects.
Perform validation tasks in support of validation or project plans.
Design validation plans, oversee execution of the plans and report validation activities on validation summary reports.
Monitor any deviation, address such to management team for change control.
Determine the need for revalidation based upon changes to systems.
Manage compliance with 21 CFR Part 11 for assigned systems.
Manage compliance with HIPAA for assigned systems.
Collaborate with other information technology groups on the validation of internal systems infrastructure.
Review internal documentation for compliance with regulations and industry guidelines.
Handle external interactions related to systems validation.
Participate in internal, external and vendor audits.
Contribute to the overall development and maintenance of policies and procedures as related to compliance activities.
Able to communicate to peers and leaders in the organization the aspects and requirements of compliance.
Ingenix is part of the family of companies that make UnitedHealth Group one of the leaders across most major segments of the US health care system.
If you get excited about the life transforming potential of bringing health care information to the right place, at the right time, to support crucial decisions, welcome to Ingenix.
We're one of the largest and fastest growing health information companies and the only organization in our industry with the information, technology and consulting expertise to solve the most significant challenges in health and human services.
As a vital member of the UnitedHealth Group family, we serve customers in every segment of the health care field. This includes government agencies, pharmaceutical companies, hospitals and health delivery networks, insurance providers and, of course, the diverse business divisions of UnitedHealth Group.
Bring your talent to an industry leader with the information, technology, and consulting expertise to help transform health and human services. No matter what your role, you'll be empowered to ask more questions, develop better solutions and help make the health care system greater than ever.
Qualifications
Qualifications:
4+ years experiences in Gxp environment with good knowledge in FDA, EMEA, MHLW Regulatory requirements - particularly HIPAA, 21 CFR Part 11
4+ years experiences authoring/reviewing system requirements, validation plan/report, testing protocol (IQ/OQ/PQ) from CSV Compliance's and regulatory requirements aspects
4+ years experiences authoring/reviewing system requirements working closely with product management and/or system users
2+ years technical experiences in software engineering, either programming or testing experiences.
4+ years experiences using Microsoft Office applications (Excel, Word, Schedule, PowerPoint)
Assets:
3+ years experience with Clinical Trails, Drug Safety Business
Diversity creates a healthier atmosphere: equal opportunity employer M/F/D/V
UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.
Job IT Quality Assurance
Primary LocationNAM-US-NJ-Basking Ridge
Organization i3 Admin
Schedule Full-time
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