- 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. (Durham, NC)
- …technical services support in the areas of equipment and automation systems , validation , deviation management and product franchise. Specific assignments ... Good Manufacturing Practices (GMP), Immunochemistry, Maintenance Engineering, Manufacturing Execution Systems (MES), Manufacturing Process Validation , Process Optimization,… more
- Merck & Co. (Durham, NC)
- …technical services support in the areas of equipment and automation systems , validation , deviation management and product franchise. Specific assignments ... years; currently Durham employs 1,000+ people. - Durham's Technology Transfer Specialist will be an energetic, technical leader with strong interpersonal,… more
- Aequor (Bothell, WA)
- …projects; ability to multi-task PURPOSE AND SCOPE OF POSITION:The Benchtop Support Specialist position will be responsible for providing IT support in our Digital ... working to support, enhance, and maintain compliance for the GxP benchtop systems and instrumentation as well as site and global applications used within… more
- Merck & Co. (Durham, NC)
- …of experience in process automation in a GMP environment.Experience programming Emerson DeltaV. Computer system validation and systems life-cycle development ... Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation . Our company is expanding its global recombinant human… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …with Explorer, Word, PowerPoint, Excel, OneNote, Project, and Teams Requires demonstrated computer skills with data management systems or data bases Ability ... systems such as 120 VAC, 24 VDC, 480 VAC GAMP guidelines Computer Maintenance Management Systems (CMMS) Understanding standard operating procedures (SOP's)… 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
- 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
- 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)
- …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
- 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
- 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
- United Therapeutics (Silver Spring, MD)
- …an engineering degree will still be considered; however, the job title will be as a Validation Specialist ) + 8+ years of relevant validation experience in a ... Datalogger Software (preferably Amphenol / Ellab) + Ability to perform validation activities for equipment, process and/or computer -related validation … 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
- BioBridge Global (San Antonio, TX)
- …to ensure successful collaboration and equipment relocation and verification and/or validation . Professionalism and diplomacy in dealing with other Departments is ... Tasks Independently design, execute, and interpret results for laboratory experiments/ validation studies to evaluate and/or validate laboratory processes, test… more
- Mentor Technical Group (Juncos, PR)
- …and quality of serialized products. Key Responsibilities: + Develop and execute validation protocols for serialization equipment, processes, and systems . + ... records for all validation activities. + Analyze validation test data to determine whether systems ...Required Skills and Qualifications: + Bachelor's degree in Engineering, Computer Science, or a related field. + Proven experience… more
- AbbVie (North Chicago, IL)
- …of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (eg Computer , Equipment, Cleaning, Process, etc.) preferred ... to plan, and complete tasks associated with commissioning, qualification and validation of new and modified equipment, facilities, utilities, product, processes… more
- The Greentree Group (Madison, WI)
- Independent Verification & Validation (IV&V) Technical Specialist + A re you a technology enthusiast who loves solving complex problems? + Do you have a keen eye ... to hear from you! ABOUT THE OPPORTUNITY As a potential Independent Verification & Validation (IV&V) Technical Specialist , you will have the opportunity to work… more
