- General Motors (Harrisburg, PA)
- …You'll Do:** + Lead the design, development, and implementation of simulation-based validation strategies for autonomous systems , ensuring safety and performance ... a critical role in leading the strategy and execution of simulation-based validation efforts for autonomous vehicle development. Your expertise will guide a team… more
- Teva Pharmaceuticals (West Chester, PA)
- …new releases, upgrades and changes in accordance with Computer Systems Validation (CSV) standards. + Perform day-to-day system administration, maintenance & ... Software Development Life Cycle (SDLC) phases for laboratory computer systems . Ensures that system implementations are in...+ Minimum 3 years of experience working in a validation analyst or similar role, preferably within the pharmaceutical… more
- Merck (West Point, PA)
- …and/or support various site functional and cross functional structures for all computerized system validation and IT/OT compliance issues. + Ensure supply and ... regulatory requirements (21CFR part 11, EMEA Annex's 11, etc) that apply to computerized systems validation and compliance for site based as well as divisional… more
- Globus Medical, Inc. (Audubon, PA)
- …Quality provides strategic leadership and oversight of the company's global quality systems , with direct responsibility for Quality Engineering at the Audubon (HQ) ... Engineering + Oversee product quality engineering, including design assurance, process validation , risk management, and post-market feedback. + Ensure robust CAPA,… more
- Datavant (Harrisburg, PA)
- …regulated data services and software. This includes oversight of software validation , privacy compliance, supplier qualification, and audit readiness. You will also ... standards. This role is essential to operationalizing Datavant's **Quality Management System (QMS)** across internal and external stakeholders and enabling continued… more
- ThermoFisher Scientific (Allentown, PA)
- …of 2 years in the pharmaceutical/related regulated industry. + Experience with process validation in Quality Systems . + Familiarity with or experience in ... in validation and qualification documentation and requirements of the system + Utmost integrity and personal responsibility are required to maintain the… more
- J&J Family of Companies (Spring House, PA)
- …to assess feasibility and performance. + Handle FAT/SAT and PPQ protocols for system qualification and validation , ensuring readiness for audits and regulatory ... control systems . + Drive continuous improvement initiatives that advance system reliability, safety, and efficiency. + Collaborate with external vendors and… more
- Merck (West Point, PA)
- …analytics, reporting, and visualization capabilities + Develop and complete appropriate system validation , Change Control and testing documentation, ensuring ... and supporting corrective actions for investigations related to automation or IT systems . + Conduct or support automation system -related investigations and… more
- J&J Family of Companies (Malvern, PA)
- …J&J sectors **External** : Manufacturing Systems and Lab Systems Technology providers, System Integrators, Regulatory agencies. **PHYSICAL ... Performance Measurement, Product Testing, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation , Standard Operating… more
- Sumitomo Pharma (Harrisburg, PA)
- …Directly manage the System Development Life Cycle (SDLC) for regulated systems , including validation planning, executing IQ/OQ/PQ protocols, and final report ... Own and enforce GxP compliance for all in-scope applications, ensuring all system activities meet requirements for validation , change control, documentation,… more
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