- 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
- 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
- VTI Life Sciences (San Diego, CA)
- …companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that ... Test Scripts. + 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation . + Must have experience working in an… more
- Curia (Rensselaer, NY)
- …team. This role is responsible for supporting Quality Management Systems and Computer System Validation efforts. Additionally, the Senior CSV Systems ... Senior QA Validation Specialist - CSV Systems...functional areas across the organization to maintain and improve computer system validation processes to… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …+ 5+ years of experience in Equipment/Facilities/Utilities Qualification experience. + 2+ Computer System Validation (CSV) experience in the pharmaceutical ... **Senior Validation Specialist ** **Position Summary** Catalent, Inc....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...completion in a Quality role. + Support the Computerized System Validation Lifecycle to ensure compliance to… more
- Actalent (Durham, NC)
- …+ Assist in the development of cGMP operating procedures related to process, computer systems , and equipment validation . + Assure compliance with ... Quality Specialist - Validation Job Description The...and determine actions for adding, removing, and/or revalidating processes, systems , and equipment. + Track and monitor process/ system… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …vessels, clean-in place systems , and parts washers. The **Senior Cleaning Validation Specialist ** also responsible for supporting the design, execution and ... **Senior Cleaning Validation Specialist ** **Position Summary** Catalent, Inc....department is responsible for ensuring that all facilities, processes, equipment/ systems and automated equipment used for GMP/GLP critical purposes… more
- Kelly Services (West Point, PA)
- …communicate with the vendor/ service engineer to identify resolutions + Participate in computer system validation activities associated with new or upgraded ... **Metrology Specialist I** **Location: 100% On-site in West Point...participating in the validation of computerized laboratory systems or instruments (eg system Installation and… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …to reliably deliver benefits for patients worldwide. Position Summary As a Senior Specialist , Validation Services, you will play a key role in supporting ... test plans, and regulatory guidelines. + Proficiency in troubleshooting equipment and systems during validation activities. + Ability to manage multiple… more
- BioBridge Global (San Antonio, TX)
- …agencies or clients. Train staff on validation protocols. Manage incoming validation tickets via the ticketing system to ensure validations are assigned ... Must be familiar with the equipment maintenance system , environmental monitoring system , and ticket management systems . Must be familiar with pulling reports… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …to reliably deliver benefits for patients worldwide. Position Summary As a Senior Specialist , Validation Services, you will play a key role in supporting ... test plans, and regulatory guidelines. + Proficiency in troubleshooting equipment and systems during validation activities. + Ability to manage multiple… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The primary responsibility for the Validation Specialist is the planning and overall approval of ... of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (eg Computer , Equipment, Cleaning, Process, etc.) preferred… more
- Astellas Pharma (Sanford, NC)
- ** Specialist , QA Validation ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to ... on Astellas, please visit our website at **www.astellas.com** . **The Role** The Specialist , QA Validation will be primarily responsible for the implementation,… more
