- Insmed Incorporated (San Diego, CA)
- …hands-on experience in a validation role with responsibility for computer systems specifically LIMS, eTMF/CTMS, and other Clinical/Manufacturing systems ... Provide strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV… more
- Cipla (Fall River, MA)
- …documents. Preparation of qualification and validation documents of equipment and computer system . Preparation and qualification of e-batch record & e-Log ... Job Title : Mfg. Validation Engineer FLSA Classification : Professional, Exempt Work...with experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive,… more
- Cipla (Hauppauge, NY)
- …General: 8:30AM - 5:00PM (may vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The incumbent to this ... (DPI, MDI, oral solid or Injectables preferred). Technical Knowledge and Computer Systems Skills Effective interpersonal relationship skills and the… more
- ValSource, Inc. (Rahway, NJ)
- …and cleaning validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 ... our regions in the US. The Commissioning, Qualification & Validation (CQV) Project Manager will interface with...guidelines, client requirements, and company SOPs. Field Verifications and system walkdowns to confirm systems meet design… more
- Insmed Incorporated (NJ)
- …years' experience in a management validation role with responsibility for computer systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other ... will include, but not necessarily limited to the following: Develop risk-based validation strategies for system implementation and changes following CSV SOPs… more
- Merck & Co. (Durham, NC)
- …above floor level. Walking, bending, crawling, and stooping is required.-Proficiency in computer systems and applications including but not limited to:- ... steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System … more
- Cipla (Fall River, MA)
- …Manufacturing Practices (GMP)/Good Distribution Practices (GDP), etc. Technical Knowledge and Computer Systems Skills Understanding of machines used in ... 5:00PM (may vary based on business needs) Reports To : Quality Assurance Manager Salary Range: $72,800 - $93,600 Purpose: The QA operation specialist (MDI) position… more
- Cipla (Fall River, MA)
- …requirements, FDA & ICH guidance requirements, etc. Technical Knowledge and Computer Systems Skills Understanding of laboratory equipment operation, ... - 5:00PM (may vary based on business needs) Reports To: Quality Assurance Manager Salary Range: $78,000 - $99,840 Purpose This position requires a strong analytical… more
- Aequor (Northborough, MA)
- …handle high value product vials in various stages of packaging completion. Use computer -based systems for data collection, data analysis, timecards, e-mail and ... support from the Quality Assurance, Materials Management, Facilities Engineering, Validation , Metrology and Manufacturing Technical Support groups. In addition,… more
- Cipla (Hauppauge, NY)
- …packaging record instructions. Collection of in-process blend, finished product, validation samples for analysis, sample collection as per protocols. Specifically, ... perform posting of dispensed materials and samples into SAP system (ERP system ) and to perform other...of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and… more
- Cipla (Hauppauge, NY)
- …packaging record instructions. Collection of in-process blend, finished product, validation samples for analysis, sample collection as per protocols. Specifically, ... perform posting of dispensed materials and samples into SAP system (ERP system ) and to perform other...of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and… more
- Cipla (Hauppauge, NY)
- …packaging record instructions. Collection of in-process blend, finished product, validation samples for analysis, sample collection as per protocols. Specifically, ... perform posting of dispensed materials and samples into SAP system (ERP system ) and to perform other...of compliance and per GMP requirement. Report, escalate to Manager quality assurance about daily shop floor activities and… 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 ... Interaction with colleagues at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation needs. + Need… more
- Washington Metropolitan Area Transit Authority (Alexandria, VA)
- …security policies for internal and external audit compliance. The Senior Manager ensures cybersecurity controls are integrated into system /software acquisition ... Sr. Manager Cybersecurity (Fusion Officer) Job ID: 251033 Location:...improvements. Develops and documents supply chain risks for critical system elements, as appropriate. Ensures WMATA systems … more
- Integra LifeSciences (Princeton, NJ)
- …or more of the areas listed below. + Controlled environment monitoring + Water system monitoring + Bacterial endotoxin test method validation and monitoring + ... direct supervision of Director, Quality Reliability Microbiology, the Sr. Manager , Microbiology Reliability - Tissue Technology will have supervisory… more
- BeOne Medicines (San Mateo, CA)
- Senior Manager , CDM Systems Administrator is responsible for leading and oversight of Data Management systems including Oracle LSH/DMW, Medidata Rave and any ... of MDM and downstream processes that impact data management systems + Develop and maintain user access management documents...of clinical database design / study build / data validation and system interoperability + Competence with… more
- Acuity Brands (Costa Mesa, CA)
- …(PDM) Manager will lead QSC's enterprise-wide product data strategy, systems , and governance across the full product lifecycle-from concept through production ... initiatives. **Skills and Minimum Experience Required** + Bachelor's degree in Engineering, Computer Science, Information Systems , or a related field. + 7+… more
- Teradyne (North Reading, MA)
- …Teradyne Compute Test Division Engineering team is seeking a hands on first level manager to lead one of our FPGA development teams. Development occurs in a dynamic ... to make complex hardware and software come together into a working system . + Manage multiple simultaneous (typically 2-3) FPGA development projects including: +… more
- Micron Technology, Inc. (San Jose, CA)
- …ever. We are seeking a highly motivated and experienced Server Ecosystem Enablement Manager to join our dynamic team within the Cloud Memory Business Unit (CMBU). ... leadership features and outstanding products. + Own and drive the enabler Platform validation function and forums, such as weekly core team meetings, bi-weekly sync,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …is responsible for supporting the design, development, documentation and execution of system verification & validation plans, protocols and reports to ensure ... that Olympus products meet published user and system requirements. **Job Duties** + Responsible for developing and...with BS (0 years with MS). + Experience with systems verification and user validation . + General… more
