Develop test methods for Design V&V, Process Validation, and Production Perform validation of test methods Execute Engineering Builds, Gauge R&R Studies, Attribute Analysis Studies, and other validation work Author/release new test methods and edit/redline old test methods Complete work related to Test Engineering that is assigned outside the scope of this specific projec

Seek to make continuous improvements to design of Automated system, execution, and automation Collaborate effectively and on an ongoing basis with various internal teams Share automation related issues and provide recommendations based on issues discovered Create a sustainable automation framework for many large scale and highly integrated applications (PLC based, DELTA V

Drive assigned program with high energy and tenacity (sometimes pulling IT SMEs and stakeholders along) Coordinate across MSPs and SI partners to ensure work is scheduled, tracked, and completed Develop project documentation, communications, and stakeholder plan development/execution Provide project and deliverable status updates, financial analysis, risk/issue tracking,

Monitor vendors/partners associated with PV function through oversight mechanism such as development and maintenance of Vendor Oversight Plans (VOPs) tailored to GPS (Global Product Safety) business needs Oversee vendor activities and act as a GPS representative on external calls with partners, vendors, etc. Manage VOP tracker, review oversight plans, and revise VOPs on a

Oversee timelines, risk, budget, and overall performance of concurrent projects throughout the project lifecycle for new development and sustaining projects Deliver projects over the complete engineering lifecycle Manage cross functional project teams in a matrix organization Coordinate project activities and deliverables between partners/suppliers Identify resource requi

Identify, develop, and maintain collaborative relationships with current and future KOLs, scientific experts, cooperative study groups, and study sites Work with key professionals at the national, regional, and local level to educate them with current medical, scientific, and pharmacoeconomic information regarding various company therapies Increase awareness of internally

Identify, develop, and maintain collaborative relationships with current and future KOLs, scientific experts, cooperative study groups, and study sites Work with key professionals at the national, regional, and local level to educate them with current medical, scientific, and pharmacoeconomic information regarding various company therapies Increase awareness of internally

Identify, develop, and maintain collaborative relationships with current and future KOLs, scientific experts, cooperative study groups, and study sites Work with key professionals at the national, regional, and local level to educate them with current medical, scientific, and pharmacoeconomic information regarding various company therapies Increase awareness of internally

Identify, develop, and maintain collaborative relationships with current and future KOLs, scientific experts, cooperative study groups, and study sites Work with key professionals at the national, regional, and local level to educate them with current medical, scientific, and pharmacoeconomic information regarding various company therapies Increase awareness of internally

Identify, develop, and maintain collaborative relationships with current and future KOLs, scientific experts, cooperative study groups, and study sites Work with key professionals at the national, regional, and local level to educate them with current medical, scientific, and pharmacoeconomic information regarding various company therapies Increase awareness of internally

Verify non conformances are thoroughly investigated, root causes are substantiated, and adequate/effective CAPA's are implemented Identify any atypical product quality trend and escalate in a timely manner Manage handling of USFDA inspections, respond to observations, and maintain current Regulatory requirements Oversee QMS documents (incident/deviation investigation, cha

Lead Cleaning Validation/Verification of OSD and Sterile manufacturing equipment for new product introductions, product/process changes for capacity, or continuous improvement projects in compliance with FDA regulations, Quality management systems, Good Manufacturing Practices Collaborate with clients and lead team members of R&D, QC, Engineering, Operations, and QA Prepa

Manage day to day operations and activities to support the start up, conduct, and evaluation of research activities of assigned sites Work with investigators to provide administrative and clinical oversight of studies to ensure efficient study start up and progress according to study timelines Evaluate and review research opportunities and new protocols from investigators

Review CDISC specifications for SDTM and ADaM datasets and Pinnacle 21 validation reports Provide QC oversight of CRO deliverables like ADaMs, and tables, listings, and figures Develop SAS or other programs/specifications for production of output to support study needs (publications, safety reporting, ad hoc analyses in a timely fashion, etc.) Verify other programmers' re

Provide QA GCP advice and support to internal Clinical Development/Operations functions and other relevant functions Plan, schedule, and conduct audits of Clinical Investigator Sites, Vendors, Partners/affiliates, and Clinical submission documents Conduct GCP training for internal staff Assist with the maintenance of the Clinical Quality Management System and ensure conti