| Agile PLM and SeniorValidationProject Manager at Remote, Remote, USA |
| Email: [email protected] |
| 4 positions in total 2 Mid level positions Has to be under 11 years Rate at $65hr c2c / $60hr W2 2 Senior positions has to be under 15 years Rate $80hr c2c / $75hr W2 Position: Agile PLM Techno-Functional Consultant (Oracle/SAP) Duration: 12+ Months Location: Hybrid at Foster City, CA ( Looking for Cali or nearby States, not accepting far off east coast based candidate ) Client: Pharma SHOULD HAVE WORKED ON SAP PLM AND AGILE PLM SHOULD HAVE BOTH ORACLE AND SAP PHARMA IS A MUST OR HEALTHCARE OR PHARMA MANUFACTURING OR ANY MEDICAL DEVICE INDUSTRY EXP.. Description: Experienced with both Agile PLM and SAP PLM. Provide day to day support to clients on handling service requests Troubleshoot and provide resolution to the issues reported by users, integration issues reported / identified Experience in PLM process definition, analysis, design and implementation. Knowledge of Agile SDK, PX, Events, WSX, ACS, Agile Import/Export, data loads, ACP. Knowledge of Distributed files management and AutoVue in Agile PLM. Extensive experience with configuration and testing SAP modules Have worked on integrations for items master or bills of material from PLM to EBS or SAP. Agile Interface with ERP applications is preferred. Experience with Item Master and Bills of Material Data Conversion or PLM integration, Process manufacturing will be a plus Experience in working in support, Oracle SRs and integration environment is a MUST. Provide support to implementation / project / Sustainment team on rolling out the new customizations Plan for the server / system maintenance activities Troubleshoot and resolve any server side / application related issues Performing periodical refresh activities, as required by Implementation / Sustainment / 3rd party teams Providing guidance to junior team members on support activities Reporting of any process deviations to leadership team Senior Validation Project Manager Location: Hybrid at Foster City, CA ( Looking for Cali or nearby States, not accepting far off east coast based candidate ) Client: Pharma Duration: 12 months Rate: $65hr W2 / $73hr c2c/1099 Pharma/ Biotech/ Life Sciences/ Medical Device/ Healthcare or Manufacturing experience is a must ( Okay with either 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. Thanks, Ashley Change/Remove SubscriptionPowered by Zoniac Siliconstar Tech, 320 Decker Drive, Suite 100, Irving, Texas 75062 Phone: 972 256 8154 Keywords: sfour wtwo California Wisconsin |
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| Mon Jan 22 22:06:00 UTC 2024 |