- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility ... the treatment of multiple myeloma.Legend Biotech is seeking QA Validation Specialist III as part of the...data integrity.Key Responsibilities Provide quality and compliance oversight for computer systems validation , process … more
- Merck & Co. (Rahway, NJ)
- …equipment and instrumentation in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new or ... Skills:Adaptability, Adaptability, Analytical Chemistry, Analytical Instrumentation, Change Management, Communication, Computer System Validation (CSV), Data… more
- Aequor (Hicksville, OH)
- …experience in filling and packaging of pharmaceutical products. Basic knowledge of computer applications, including SHAPE system and Microsoft Office. Proficient ... Packager - Support Specialist 2nd shift Packaging = /hr pay rate...upcoming batches. Sets up and monitors cleaning and filling Validation batches according to protocols. Accepts and controls labels… more
- Evotec (Redmond, WA)
- …and the ability to manage multiple priorities. Preferred Qualifications Experience with computer system validation (CSV) and risk-based approaches under ... Job Title: Principal Automation/Process Control Engineer - DeltaV Specialist (GxP Biologics Manufacturing) - Global MSAT Location: Redmond, WA Department: Global… more
- StateJobsNY (Albany, NY)
- … Computer Science, Criminal Justice, Economics, Econometrics, Finance, Information Systems , Information System Engineering, Internal Controls, Health, Health ... Services seeks to build an equitable, transparent, and resilient financial system that benefits individuals and supports business. Through engagement, data-driven… more
- Macpower Digital Assets Edge (Los Angeles, CA)
- Job Summary: The Customer Solution Center Audit Readiness Specialist II is responsible for the execution, oversight, and monitoring of the guidelines and protocols ... management. Collaborates with business units in audit universe preparation and validation . Assists in document preparation for regulatory and internal audits.… more
- Sotera Health Services, LLC (Itasca, IL)
- Job Description Regulatory Affairs oversees the quality system and uses a risk based approach to ensure regulatory compliance for Nelson Labs. Department processes ... complaints, management review, and regulatory agency interactions. The Regulatory Specialist is primarily responsible for executing internal and external audit… more
- United Nations (New York, NY)
- …Secretariat. DCO exercises managerial and oversight functions of the resident coordinator system under the collective ownership of the members of the United Nations ... An advanced university degree (Master's degree or equivalent) in computer science, data science, analytics, statistics, applied mathematics, information management,… more
- GRIFOLS, SA (Clayton, NC)
- …and Excel) to create, edit, and format documents Ability to work with other computer systems for filing supplements and reports. Ability to interpret and ... a very timely and accurate manner. Sr Reg Affairs Specialist I Primary responsibilities for role: Act as Regulatory...state, and local levels. Ability to work with other computer / software systems as needed. Ability… more
- LanceSoft (Memphis, TN)
- … System (QS) Regulation & Medical Device Good Manufacturing Practices 3. Process Validation and Computer software validation knowledge. 5. Computer ... packaging development Nice to Have: 1. Design and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO… more
- ATR International (Memphis, TN)
- …Devices 2 Equipment Commissioning / Qualification 3 Process Validation 4 Computer System Validation (CSV) 5 Manufacturing, Packaging and Laboratory ... and may support prototype line development in manufacturing facilities/plants SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in… more
- ChargerHelp (Los Angeles, CA)
- …Use of electrical testing tools (multimeter, insulation resistance testers, etc.) for system validation and diagnostics. Low Voltage & Networking: Basic ... electrical, or technical malfunctions. Your electrical expertise will ensure these systems are not only functional but also pristine, code-compliant, and operating… more
- Anduril Industries (Atlanta, GA)
- …taking products like Ghost, Anvil, Bolt and Altius from paper sketches to operational systems . We work in close coordination with specialist teams to solve some ... to the defense industry, Anduril is changing how military systems are designed, built and sold. Anduril's family of... is powered by Lattice OS, an AI-powered operating system that turns thousands of data streams into a… more
- Virginia Jobs (Norfolk, VA)
- …and requirements. Minimum Qualifications *Ability to work as stand-alone administrative specialist in the NROTC Unit. *Well versed in university policies and ... standard English grammar, spelling, punctuation and basic math. - Advance computer skills to include proficiency in Microsoft office applications, Knowledge of… more
- LanceSoft (Louisville, CO)
- Must Have: Equipment and Software Validation Experience Nice to Have: Experience working in Medical Device Field JOB DESCRIPTION The Primary function of this ... Requirements. Requires a 4 year degree in Engineering or Computer Science and minimum of 4 years of relevant...are required for the role: Software, Process and Equipment Validation experience Experience working in Medical Device or other… 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 ... completed by an external company, the computer systems validation (CSV) specialist will...In depth understanding and knowledge of successfully validating a computer system to meet all FDA and… more
- Kedrion Biopharma (Melville, NY)
- …audit trails, access controls, data migration, and backup._ + _Own and maintain system validation procedures and documentation across the site._ + _Partner with ... _Kedrion is looking for a_ **_Validation Specialist - Computer Systems_** _to join...GAMP 5 standards._ **_Job Role and Responsibilities_** + _Lead validation projects for GxP systems -authoring and executing… more
- Cognizant (Muskegon, MI)
- …engineering project work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The ... Sr/Lead CSV Specialist Cognizant Technology Solutions in LSMG is seeking...MES, ABB as well as other DCS and OT systems . **Requirements** : The Validation Lead responsibilities… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated **Senior Validation Specialist - CSV** to ensure compliance of computerized systems with regulatory ... 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical day might include:**... validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing,… more
- Boehringer Ingelheim (St. Joseph, MO)
- …high regard for our employees. The Principal Specialist , CSVC oversees all aspects of computer system and computer system and computerized equipment ... effectively supporting moderate to complex projects. + Thorough understanding of computerized system validation requirements for GxP systems as expressed… more
