, and validation) Troubleshoot a variety of analytical assays, including but not limited to: HPLC (SEC, AEX/CEX, RP, etc) CE-NR, CE...
transfer, development, and validation of production methods associated with finished dosage form (FDF) drug products... and radioisotopes. Participate in technical transfer and process validation activities in collaboration with other departments. Safely...
Roles & Responsibilities: Play a client facing Compliance Lead role in projects, programs, and support work. Provide... Education & Experience: Minimum of 5 years' experience as a Computer System Validation Consultant in a regulated environment...
will collaborate with study teams to deliver standardized data collection methods and innovative validation solutions for use in global..., database, and observed datasets) · Support submission, inspection and regulatory response activities · Lead cross Business...
located in Indianapolis, IN and will be an on-site role. In this role, you will have the opportunity to: Lead product... specifications. Develop and execute component and system tests for performance validation. Participate in design reviews and ensure...
are capable of meeting and continuing to meet requirements for quality, cost, delivery and lead time. Adhere to process change... non-compliances. Lead problem solving/corrective action groups made up of cross-functional team members. Create...
related to Computer Systems Validation (CSV). Assemble global feedback on proposed or existing standards and tools... Assurance oversight/support for IT4IT systems (and some business domains) with regard to Computer Systems Validation...
analysis and risk assessments throughout the product lifecycle. Lead internal and external audits, including preparation..., and validation activities. Review and approve design control and risk management documentation. Assess and qualify suppliers...
and inform lead selection decisions Provide rapid analytical insights and data-driven feedback to upstream, downstream..., optimization, validation, and method transfers Proficiency using electronic laboratory notebooks and authoring SOPs, protocols...
direction of the Site Lead, contributing to specific project tasks that align with Project Farma's services. Perform assigned... or project challenges to the Site Lead for further action. Maintain professional relationships with project team members...
, tooling phase, model validation testing, and product launch. Qualifications Pursuing a B.S. in Mechanical Engineering.... Join us to lead progressive growth and make a significant impact within a leading organization. Here are some of the benefits...
's, and regulatory standards to support team in compliance of validation effort Independent verification of testing... technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes...
requirements, and lead best practices across Kubernetes, AWS, Cloudflare and AI. You will own the infrastructure end-to-end... Architect and lead deployment of HIPAA-compliant AWS infrastructure Define and enforce cloud infrastructure standards, patterns...
commissioning, qualification, and validation activities Represent TS/MS team to the IDAP Site Lead team Provide technical support.../Deliverables: Own Tech Transfer and Validation strategy for the manufacturing site Participate in equipment/product/format...
Discovery: Collaborate with a Product Manager and Engineering Tech Lead to drive the end-to-end product discovery process... insights. Prototype for Learning and Validation: Leverage prototyping as a primary tool for product discovery. Create...
their interaction to support business processes. · Must have a strong understanding of corporate computer system validation... requirements according to Lilly Quality Standards to lead the definition or design reviews and gathering of requirements...
. As a Firmware Engineer Manager, you will lead the design, implementation and validation of a completely new protocol whilst... a key lead or manager of a team before, this is your opportunity to make a real difference in the future of wearable tech...
at a cutting-edge AI startup that's redefining human-computer interaction. As VP of IC Design, you will lead the development... and mentoring a world-class IC design team, and driving execution from concept to tapeout. If you're looking to lead from the...
Job Description Summary At Novartis, you can lead with purpose and shape how life‑changing radioligand therapies reach... States Job Description Key Responsibilities: - Lead daily quality control laboratory operations to ensure timely...
impacts to schedule critical paths. Provide guidance on design issues, client concerns and code issues. Lead project...’ schedules for as-planned schedule validation, labor productivity, critical path delay and acceleration. Development of risk...