Highlights
Minimum 5 years' experience in Computer System Validation (CSV), CSA, Automation Compliance, Shopfloor, Enterprise, Lab and Quality Systems within a regulated pharmaceutical or biotechnology environment. • Candidates will need to be legally authorized to live and work in the United States and be willing to commute to site approximately three days per week.
Numbers & Facts
| Location | Secaucus, NJ |
| Industry | Computer Software |
| Company Size | 20 to 49 employees |
| Year Founded | 2014 |
| Website | http://www.tekfortune.com/ |
Description
Role - Computer System Validation (CSV) Analyst
Location - WestPoint, PA (Hybrid, must visit site 3 days a week)
Job Description-
• Lead CSV compliance activities for capital and strategic projects.
Must have worked in CSV in Manufacturing automation systems like DELTA V,PI Historian, PLC, LAB Automation Systems(any one pf the systems or all).
• Develop, Review and approve validation lifecycle deliverables in accordance with applicable SOPs and regulatory requirements, such as CFR 21 Part 11.
• Provide compliance guidance to project teams on SDLC, CSA, qualification, and validation approaches.
• Participate in project meetings and CSV compliance reviews.
• Assist with project change controls, and CSV compliance-related risk assessments.
• Maintain project CSV compliance trackers, metrics, and reporting.
• Approval of SDLC documents as technical unit
• Minimum 5 years' experience in Computer System Validation (CSV), CSA, Automation Compliance, Shopfloor, Enterprise, Lab and Quality Systems within a regulated pharmaceutical or biotechnology environment.
• Strong knowledge of:
• GAMP 5
• FDA 21 CFR Part 11
• EU GMP Annex 11
• Risk-based validation and CSA principles
• Software Development Lifecycle (SDLC)
• Change Management and Deviation processes
• Experience supporting capital projects and GMP computerized systems.
• Strong stakeholder management and communication skills.
• Ability to work independently across multiple projects and sites.
• Role based in West Point, PA (Must visit site 3 days a week)
• Candidates will need to be legally authorized to live and work in the United States and be willing to commute to site approximately three days per week.
About Company
Tekfortune is a software solutions company providing project development and staff augmentation services to companies in various industries including Healthcare, Banking, Finance, Telecommunication and Aviation.
Tekfortune Inc delivers solutions to a wide variety of organizations of various sizes and industries. Our clients include mid-market to Fortune 1000 companies spanning across industries such as: Insurance, Financial, Pharmaceutical, Manufacturing, Retail and many others.
In Tekfortune Inc, we are offering selection of services and solutions at very reasonable rates. With years of experience in the placement and recruitment Industry and over time we have acquired the knowledge essential to comprehend the exact need and dependence on customers. Therefore we provide the customers the best and also the brightest candidates for vacancies. Moreover, by understanding the working interest of customers who is able to place them within the companies where they are able to get maximum opportunity for professional growth.
Tekfortune Inc has a strong emphasis on quality. Its goal would be to achieve client satisfaction by looking into making deliveries satisfaction of customer's business needs. Our ability to quickly identify and effectively employ proven fundamental principles, techniques and resources yields highly desirable results for our clients.
We understand that each industry and organization share a level of uniqueness that requires a tailored approach in order to deliver specific solutions. Such factors as client culture, industry regulations, organizational maturity, financial health and many more items may impact our approach to delivering client solutions.
Having served a wide variety of clients has provided Tekfortune the ability to build subject matter expertise across numerous industries. Our industry expertise combined with our specialized knowledge of Business Process Improvement, Requirements Management and Program & Project Management provides a powerful combination and a tremendous value to our clients.
We are run by a group of industry experts who have decades of experience in delivering custom solutions to our clients.
Tekfortune Inc delivers solutions to a wide variety of organizations of various sizes and industries. Our clients include mid-market to Fortune 1000 companies spanning across industries such as: Insurance, Financial, Pharmaceutical, Manufacturing, Retail and many others.
In Tekfortune Inc, we are offering selection of services and solutions at very reasonable rates. With years of experience in the placement and recruitment Industry and over time we have acquired the knowledge essential to comprehend the exact need and dependence on customers. Therefore we provide the customers the best and also the brightest candidates for vacancies. Moreover, by understanding the working interest of customers who is able to place them within the companies where they are able to get maximum opportunity for professional growth.
Tekfortune Inc has a strong emphasis on quality. Its goal would be to achieve client satisfaction by looking into making deliveries satisfaction of customer's business needs. Our ability to quickly identify and effectively employ proven fundamental principles, techniques and resources yields highly desirable results for our clients.
We understand that each industry and organization share a level of uniqueness that requires a tailored approach in order to deliver specific solutions. Such factors as client culture, industry regulations, organizational maturity, financial health and many more items may impact our approach to delivering client solutions.
Having served a wide variety of clients has provided Tekfortune the ability to build subject matter expertise across numerous industries. Our industry expertise combined with our specialized knowledge of Business Process Improvement, Requirements Management and Program & Project Management provides a powerful combination and a tremendous value to our clients.
We are run by a group of industry experts who have decades of experience in delivering custom solutions to our clients.