- Lilly (Pleasant Prairie, WI)
- …application of data management and integrity principles in operational processes, and Computer System Validation methodologies to ensure regulatory ... data management and integrity principles in operational processes, and Computer System Validation methodologies to...both locally and across global M&Q. Act as the Computer systems validation quality assurance… more
- 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
- ThermoFisher Scientific (Santa Clara, CA)
- …testing or FAT is a plus. Familiarity with Computer System Validation (CSV) concepts. Experience with automation systems such as DeltaV, PLC/SCADA, or ... glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As a Validation Engineer II, you will support validation and qualification activities for… 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
- AbbVie (Somerville, NJ)
- …of significant engineering and/or operational experience. Process and Cleaning Validation Experience Equipment Qualification (IOQ/PQ) Quality System Experience ... of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (eg Computer , Equipment, Cleaning, Process, etc.) preferred… more
- Lilly (Lebanon, IN)
- … Plan. Provide subject matter expertise for computer system validation and data integrity for automation systems across the site including: Process ... skills for both technical and non-technical audiences Knowledge of GMP, regulatory requirements, computer system validation Basic Requirements: Minimum BS in… 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 (Atlanta, GA)
- …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
- Lilly (Indianapolis, IN)
- …skills for both technical and non-technical audiences Knowledge of GMP, regulatory requirements, computer system validation Basic Requirements: Minimum BS in ... in major pharmaceutical companies and in Manufacturing Operations with extensive System integration of applications, systems and platforms Additional… more
- United Therapeutics (Silver Spring, MD)
- …prioritize workload Manufacturing or Quality system application support experience Computer hardware / software validation and change control experience ... integrity requirements. Ensure the continuous, uninterrupted availability and functionality of computer systems , and coordinate appropriate resources to respond… 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
- Lilly (Lebanon, IN)
- …skills for both technical and non-technical audiences Knowledge of GMP, regulatory requirements, computer system validation Basic Requirements: Minimum BS in ... with the purpose of ensuring that reliable and compliant control applications and systems are used in the manufacturing at Foundry. Additionally, the Engineer as a… more
- General Motors (Columbus, OH)
- Job Description Role: As a Staff Software Systems Engineer on the Behavior Validation team within the AV organization, you will play a critical role in leading ... experience in system engineering and requirements management including system analysis, requirements authoring, test generation, and validation activities… more
- Apple (Cupertino, CA)
- …consumer products that set new standards of excellence. As an iPhone Hardware Systems Validation Engineer (SysVE), you will be a key contributor who ... contribute to mitigating project risks while engineering the future of innovation. Description As System Validation Engineers, we love the impact we make on the… more
- General Motors (Mountain View, CA)
- …Description Hybrid: This role is categorized as hybrid. Role: As a Senior Software Systems Engineer on the Software Validation team within the AV organization, ... experience in system engineering and requirements management including system analysis, requirements authoring, test generation, and validation activities… more
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