- NTT DATA North America (Pittsburgh, PA)
- …workflows. Experienced in delivering projects in regulated environments, ensuring compliance with FDA Computer Systems Validation (CSV) and quality ... with PMO governance, documentation standards, and regulatory requirements (eg, FDA CSV). Drive continuous improvement by identifying opportunities to streamline… more
- Medtronic (Lafayette, CO)
- …including warrantee, service, and repairs. + Experience implementing and adhering to FDA and computer systems validation requirements. + Demonstrated ... to be independently mobile. The employee is also required to interact with a computer , and communicate with peers and co-workers. Contact your manager or local HR to… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that ... coordinating, working, and communicating with personnel across multiple departments. Performs validation activities related to the implementation of computer … more
- PCI Pharma Services (Bedford, NH)
- …team. In this role, you'll take the lead in developing and executing validation strategies for GxP computer systems-ensuring everything from equipment to ... highest regulatory and performance standards. **What You'll Do:** + Lead validation activities throughout the computer system lifecycle-including plans,… more
- Jabil (Hunt Valley, MD)
- …of drug and medical device overall validation activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process ... in compliance with global regulatory requirements ( FDA , EMA, ICH, etc.)aseptic fill-finish environment and ensuring the...teams. + Provide oversight and strategic direction for the Computer System Validation (CSV) program and supervise… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Senior Validation Specialist I, BioAnalytics Computer System Validation (CSV) & Compliance** **Position Summary:** Catalent, Inc. is a leading global ... Validation Specialist is primarily responsible for leading, implementing and managing Computer System Validation (CSV) and Data Integrity Programs (DI),… more
- Curia (Albuquerque, NM)
- Validation Analyst II, Albuquerque, NM Build your future at Curia, where our work has the power to save lives Curia is a global contract development and ... Validations Department is responsible for formulating, reviewing, and approving all validation protocols related to manufacturing or support operations. The … more
- Endo International (St. Louis, MO)
- …and review. The position will also have responsibilities for the review/approval of validation activities for enterprise computer system software and other ... leads. + Interaction with colleagues at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation needs. +… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …risk assessments, traceability matrices, and validation master plans. + Develop validation protocols (IQ/OQ/PQ) for computer systems as applicable to its ... MES, ERP, SCADA, or DCS (eg, Delta V) for computer systems validation engineers. + Advanced knowledge...required. + Familiarity with software development lifecycle (SDLC) and validation tools. + Knowledge of GAMP 5, FDA… more
- Curia (Albuquerque, NM)
- …and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), environmental ... mapping and use of Kaye Validator + Experience with FDA and EU regulations for pharmaceuticals and validation...form and deal with several abstract and concrete variables. Computer Skills: The ideal candidate will possess a strong… more
- Capgemini (Chicago, IL)
- …world. **Job Description** **About the job you're considering** We are seeking a Validation Lead to drive Computer System Validation (CSV) initiatives. ... Good Documentation Practices (GDP) **Your skills and experience** + Computer System Validation (CSV) expertise, including hands‑on... approaches. + Strong working knowledge of GxP regulations, FDA 21 CFR Part 11, EU Annex 11, and… more
- Bristol Myers Squibb (Devens, MA)
- …Process Flow diagrams and Standard Operating Procedures. + Knowledge of regulatory validation requirements including FDA , EMA and all other Worldwide Regulatory ... personal lives. Read more: careers.bms.com/working-with-us . **Position:** Senior Manager Validation Engineering **Location** : Devens, MA **Key Responsibilities:** +… more
- Genentech (Hillsboro, OR)
- …therapies to patients. This role is a part of our Quality Systems and Validation (QSV) team, which is dedicated to supporting the design, startup, and operation of ... Development, and Global Quality to define and implement robust Quality Systems, Validation strategies, and automated QC methods that ensure compliance with cGMP… more
- Sumitomo Pharma (Indianapolis, IN)
- …drug/device combination products) is required. Must be familiar with EMA and FDA validation requirements, including Lifecycle Model. Lean Six Sigma ... and experienced individual for the position of **Director, Commercial Manufacturing Validation ** . This role functions within SMPA's Global Technology and Quality… more
- Insight Global (Indianapolis, IN)
- …Qualification, Validation ) or IQ OQ PQs protocols within an FDA regulated environment for their pharmaceutical customer. Pharma experience is not required ... have experience managing an environment with human safeties involved. It could be a computer system validation process or a validation equipment process,… more
- Danaher Corporation (Chaska, MN)
- …Knowledge of FDA regulations, ISO standards, and GxP guidelines. + Experience with Computer System Validation (CSV) and process validation It would be a ... Business System (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The QA Validation Engineer is responsible for assisting in the sustainment… more
- Cognizant (Boston, MA)
- … to guarantee seamless integration across platforms and systems. * Manage Computer System Validation (CSV) activities in alignment with global regulatory ... **About the role** As a Validation Lead - MES Serialization, you will make an...standards ( FDA , EMA, MHRA). * Utilize ALM tools to streamline testing… more
- IQVIA (Durham, NC)
- …proper implementation of Software Development Lifecycle (SDLC) methods as they relate to Computer Systems Validation (CSV), IT Quality Systems, and Technology in ... reports. * Experience working in auditing and compliance of Computer Systems within an FDA regulated environment,...compliant with 21CFR Part 11. * Expert knowledge of Computer Systems Validation (CSV) in a life… more
- Rochester Regional Health (Rochester, NY)
- …Compliance Principal is responsible for leading and executing IT risk-based computer systems validation and associated technical compliance initiatives within ... GLP, laboratory and other regulations. This hybrid role combines technical hands-on computer systems validation and regulatory compliance execution. The role… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... and process development and improvement, implementation of product/process verification, validation activities, and commercialization. Responsibilities for this role also… more