- 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …risk assessments, technical studies, and any associated documentation in support of computer systems validation , equipment, utilities, and facility ... validation , and data integrity.Key ResponsibilitiesProvide quality and compliance oversight for computer systems validation , process validation ,… 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 ... qualification, validation of Pharmaceutical and Biotech GMP manufacturing facility systems and equipment. Validation Execution: Field Execute and oversee… 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 ... as needed to support the Specialty Generics organization. Software systems may be local or hosted solutions. The candidate...at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation … more
- Curia (Albuquerque, NM)
- …equipment and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), ... validation protocols for processes, equipment, utilities, and test systems . The role also supports new product introductions, equipment...the review of changes made under the Change Control System from a validation perspective + Provide… more
- Curia (Albany, NY)
- … Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and ... matching contributions + Learning platform + And more! Responsibilities Computer Systems Validation + Manage...stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation… more
- Caris Life Sciences (Irving, TX)
- …Supports the authoring and reviewing of pre-defined deliverables as identified in the Computer System Validation Process and applicable Software ... expert for software development of medical device and computerized systems . **Job Responsibilities** + Authors (as needed) and ensures...development and validation practices comply with Caris's Computer System Validation Process. +… more
- Insmed Incorporated (NJ)
- …seeking an experienced leader to oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation (CSV) program. This role will ... landscape and protect sensitive patient and research data.Demonstrated experience leading a Computer Systems Validation team in a regulated (pharmaceutical,… more
- Formation Bio (New York, NY)
- …Practices (GLP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation (CSV).The primary responsibilities for ... development organization, there is a substantial component of oversight for the computer systems validation . The implementation of the QA strategy will… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …strongly preferred.Experience with Manufacturing Execution Systems (MES) design/development and validation is preferred.Experience with Computer System ... manufacturing and protocol-driven activities such as tech transfer and process validation .Assist in the development of process, operational, and quality improvements… more
- Parexel (Columbus, OH)
- …and installation, performance or coordination of routine maintenance, computer system validation , and regulated systems retirement **Qualifications -** ... or other specialized computerized systems ** + Familiarity with standalone computer system validation requirements + Highly organized, and capable of… 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
- Syner-G BioPharma Group (Boston, MA)
- …production systems , with a concentration on computerized equipment and systems validation .Report writing experience for IQ, OQ, PQ, and CSV.Knowledge, ... (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems , equipment, and processes for (re)qualification/(re)verification.Support validation … more
- Cipla (Hauppauge, NY)
- …(DPI, MDI, oral solid or Injectables preferred). Technical Knowledge and Computer Systems Skills Effective interpersonal relationship skills and the ... to departmental SOPs, periodic review and reporting of the environmental monitoring system . Generate, review, approve and maintain Validation Master Plan and… more
- International (Elmendorf, TX)
- …plans and create innovative test procedures tailored to HVAC and cooling system evaluations + Execute validation activities according to engineering standards ... performance, reliability, and compliance of HVAC and vehicle cooling systems . Your expertise will directly contribute to the delivery...(eg, H-1B status) Desired Skills + Experience in HVAC system design or validation , or a strong… more
- International (Elmendorf, TX)
- …and solutions to our customers. We currently have a great opportunity for a Validation Project Engineer on our TRATON USA's R&D Team. This is an exciting opportunity ... to be hands-on with physical testing, validation , and development of commercial vehicle components-including cabs, doors, interiors, exteriors, hoods, steering … more
- Micron Technology, Inc. (Boise, ID)
- …world uses information to enrich life for all. **Position Overview** As a Validation Engineering Intern, you will work closely with Micron's Module Development Teams ... + Evaluate signal and power integrity of memory modules using PC systems , test platforms, and oscilloscopes. + Provide timely feedback and debug support… more
- Infinity Systems Engineering (Colorado Springs, CO)
- …-level consistency and alignment. + Support model-based reviews, technical documentation, and system validation efforts. + Define and document interfaces, ... The ideal candidate will contribute to the definition, analysis, and validation of systems architecture and requirements using industry-standard MBSE… more
- San Diego Housing Commission (San Diego, CA)
- …and resolve system errors and data discrepancies. Familiarity with system integrations and data validation best practices. Typical Qualifications Education ... & Experience Bachelor's degree in Computer Science, Information Systems , or related field. Minimum 4 years of experience in enterprise application support or … 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 ... reviews, and audit trail reviews.What You'll Do: Develop risk-based validation strategies for system implementation and changes...Clinical/Manufacturing systems .Minimum of a Bachelor's Degree in Computer … more
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