| Open Roles - 1/5/2024 at Foster City, California, USA |
| Email: [email protected] |
| Senior Validation Project Manager Location: Foster City, CA ( Hybrid ) Client: Pharma Duration: 12 months Rate: $60hr W2 / $67hr c2c/1099, Ok with H1bs Look for local candidates or from nearby to mid west who can relocate, not accepting far off east coast based candidates Pharma/ Biotech/ Life Sciences/ Medical Device/ Healthcare or Manufacturing experience is a must ( Okay with any one of these industry ) Overall 10 15 years experience required Responsibility: This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, and GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11. Leads the effort to manage, and/or maintains validation of SAP S/4 HANA system. Perform GxP and 21 CFR part 11 assessments and develop validation plan. Develop functional risk strategy and perform functional risk assessment. Review user business process documents and user requirements specification. Review functional, technical and configuration design documents. Prepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols. Review the test scripts for the requirements and test scenario coverage. Lead overall protocol executions, log and track defects. Review the executed test reports for the proper documentation of test results and evidence. Review the defects for proper documentation per the checklist. Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested. Prepare and approve qualification summary report. Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics. Maintain overall project and issue tracker and report routinely. Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release. Review Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials. Maintain day to day activities status tracker and report routinely. Lead the team of validation engineers located in different time zones. Skills: Excellent communication (oral and written) and attention to detail. 8+ years in Computer System Validation in Life Science domain with minimum 3+ years of experience in managing large global SAP validation projects. Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude. Excellent knowledge of GxP regulations, FDA and EMEA (European Medicines Evaluation Agency ) guidelines including 21 CFR Part 11. Excellent knowledge of computer system validation and GAMP -5 standards. Role Two roles: MOVEit Sr. Technical Lead MOVEit Technical Lead Job ID RFO #23-029 Client Name DHCS Location Remote Duration 24 months Rate 65hr W2 or $73 hr c2c Okay with H1s Degree Copy Yes References Yes 3 Project Summary DHCS seeks consulting services for its mission-critical MOVEit application, facilitating secure file transfers with sensitive data. Expert support staff is required to troubleshoot, repair, and perform necessary software updates 24/7. MOVEit is vital for DHCS operations, enabling external entities to automate confidential file transfers securely, including hospitals and government agencies. MOVEit Senior technical lead: Mandatory Qualifications: Eight (8) years of Full Time Equivalent (FTE) experience aligning IT systems with organizational business processes. At least five (5) years of that experience must have been in a lead capacity. A Bachelors Degree in an IT-related or Engineering field. Five (5) years of FTE experience managing the MOVEit application by Progress. Ten (10) years of FTE experience in a customer support role assisting users with a mission critical workload or application both internally and externally. Five (5) years of FTE experience working with Microsoft SQL (Structured Query Language) Server 2012 and above. Ten (10) years of FTE experience in customer service support with providing Tier 3 support for mission critical applications. Desirable Qualifications: 3 years Experience deploying patches to Windows Server using Microsoft System Center Configuration Manager (SCCM). 3 years Experience supporting mission critical applications, including both custom and commercial applications that use Microsoft SQL server. 5 years Experience configuring servers, security groups, and service accounts to meet strict security policies, including customization of security policies. 5 years Experience managing Secure File Transfer Protocol applications. 4 years Experience troubleshooting Windows Server infrastructure at an advanced level. 5 years Experience managing an Azure Active Directory (AD) environment and on-premises Active Directory environment. 5 years Networking experience troubleshooting both physical and virtual networking issues both internally and externally. 5 years Experience troubleshooting and managing Domain Name Server using InfoBlox and Windows Server Domain Name Server. MOVEit technical lead: Mandatory Qualifications: Five (5) years of FTE experience aligning IT systems with organizational business processes. At least three (3) years of that experience must have been in a lead capacity. A Bachelors Degree in an IT- related or Engineering field. Four (4) years of FTE experience managing the MOVEit application by Progress. Five (5) years of FTE experience in a customer support role assisting users with a mission critical workload or application both internally and externally. Five (5) years of FTE experience of working with Microsoft SQL Server 2012 and above. Ten (10) years of FTE experience in customer service support with providing Tier 3 support for mission critical applications. Desirable Qualifications: 3 years Experience deploying patches to Windows Server using Microsoft System Center Configuration Manager. 3 years Experience supporting mission critical applications, including both custom and commercial applications that use Microsoft SQL server. 5 years Experience configuring servers, security groups, and service accounts to meet strict security policies, including customization of security policies. 5 years Experience managing Secure File Transfer Protocol applications. 4 years Experience troubleshooting Windows Server infrastructure at an advanced level. Thanks, Ashley Change/Remove SubscriptionPowered by Zoniac Siliconstar Tech, 320 Decker Drive, Suite 100, Irving, Texas 75062 Phone: 972 256 8154 Keywords: sfour active directory information technology wtwo California Idaho Wisconsin |
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| Fri Jan 05 20:49:00 UTC 2024 |