- 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)
- …company's Research Laboratories Division is seeking applicants for a Metrology and Validation Specialist position available at the Rahway, New Jersey research ... facility. The Metrology and Validation Specialist will work as part of...in both GMP and non-GMP environment Participate in laboratory computer system validation activities associated with new… more
- Evotec (Redmond, WA)
- …and the ability to manage multiple priorities. Preferred Qualifications Experience with computer system validation (CSV) and risk-based approaches under GAMP5 . ... Job Title: Principal Automation/Process Control Engineer - DeltaV Specialist (GxP Biologics Manufacturing) - Global MSAT Location: Redmond, WA Department: Global… more
- StateJobsNY (Albany, NY)
- … Science, Criminal Justice, Economics, Econometrics, Finance, Information Systems , Information System Engineering, Internal Controls, Health, Health Administration, ... Services (DFS) is seeking candidates for the position of Data Analysis Specialist in the Economic Research Unit within the Research and Innovation Division.… more
- Sotera Health Services, LLC (Itasca, IL)
- …complaints, management review, and regulatory agency interactions. The Regulatory Specialist is primarily responsible for executing internal and external audit ... processes. The Regulatory Specialist acts as the main representative of Nelson Labs...issues Ability to be proactive in continuous improvement of systems , processes, and procedures Must be solution driven and… 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
- United Nations (New York, NY)
- …An advanced university degree (Master's degree or equivalent) in computer science, data science, analytics, statistics, applied mathematics, information management, ... data management, information systems , information science or a related quantitative field. A...ability to develop and assess performance metrics by leveraging validation techniques is desirable. Languages English and French are… more
- LanceSoft (Memphis, TN)
- …Quality System (QS) Regulation & Medical Device Good Manufacturing Practices 3. Process Validation and Computer software validation knowledge. 5. Computer ... established by ISO 11607-1 (Part 1: Requirements for materials, sterile barrier systems and packaging systems ) and corresponding packaging ASTM and ISTA… more
- ATR International (Memphis, TN)
- …Change control of Medical Devices 2 Equipment Commissioning / Qualification 3 Process Validation 4 Computer System Validation (CSV) 5 Manufacturing, ... 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)
- …electrical, or technical malfunctions. Your electrical expertise will ensure these systems are not only functional but also pristine, code-compliant, and operating ... to the Field Service Manager and receive specialized training to become a specialist in maintaining the backbone of electric mobility. Traveling is necessary for… 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 ... most innovative companies to the defense industry, Anduril is changing how military systems are designed, built and sold. Anduril's family of systems is… 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 ... Specifications. If completed by an external company, the computer systems validation (CSV) specialist will be responsible for obtaining these documents… more
- Kedrion Biopharma (Melville, NY)
- _Kedrion is looking for a_ **_Validation Specialist - Computer Systems_** _to join our team and play a critical role in ensuring the compliance and reliability ... EU, and GAMP 5 standards._ **_Job Role and Responsibilities_** + _Lead validation projects for GxP systems -authoring and executing protocols and documentation… more
- Boehringer Ingelheim (St. Joseph, MO)
- …similar manufacturing environment. + Relevant experience must include conducting computerized systems validation in a regulated industry such as pharmaceutical ... similar manufacturing environment. + Relevant experience must include conducting computerized systems validation in a regulated industry such as pharmaceutical… more
- Curia (Rensselaer, NY)
- Senior QA Validation Specialist - CSV Systems...experience working in a cGMP regulated industry specific to computer systems validation + ... Engineer Summary: The Senior QA Validation Specialist - CSV Systems Engineer is an...team. This role is responsible for supporting Quality Management Systems and Computer System Validation … 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
- 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
- Catalent Pharma Solutions (St. Petersburg, FL)
- **Senior Validation Specialist ** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission ... offer a broad range of integrated formulation. The **Senior Validation Specialist ** with guidance from the ...procedures and processes to assure that Catalent facilities, equipment, computer , and supporting systems are fit for… more
- Catalent Pharma Solutions (Harmans, MD)
- …This position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for the ... **Lead Specialist , QA Validation & Engineering** Catalent...as IQ/OQ/PQ for various equipment such as bioreactors, chromatography systems , controlled temperature units, filling/stoppering machines, autoclaves and critical… more
