- 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 ... 11, GAMP 5, Good Clinical Practices, GMPs, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing… 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, ... and/or technical experience required.Experience with cGMP Manufacturing within an FDA -regulated manufacturing company.Knowledge of cGxP Quality Systems within… 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
- Cipla (Hauppauge, NY)
- …(DPI, MDI, oral solid or Injectables preferred). Technical Knowledge and Computer Systems Skills Effective interpersonal relationship skills and the ... SOPs, periodic review and reporting of the environmental monitoring system . Generate, review, approve and maintain Validation ...Perform gap assessments and remediation as required on legacy validation packages. Interface with the FDA and… 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 ... guidelines, client requirements, and company SOPs. Field Verifications and system walkdowns to confirm systems meet design...Experience with project management, good documentation practices, cGMP, & FDA validation methods and systems ,… 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 ... Annex 11, GAMP 5, Good Clinical Practices, Data Integrity.Knowledge of the FDA Computer Software Assurance (CSA) fundamental concepts.Strong technical writing… more
- AUROBINDO (Durham, NC)
- …in risk assessments and impact analysis for system changes.Support validation activities including IQ/OQ/PQ for IT systems .Maintain QA documentation in ... systems .Excellent documentation and communication skills.Familiarity with risk-based validation approaches.Education & ExperienceBachelor's Degree in Computer … more
- Insmed Incorporated (NJ)
- …hands on experience in a validation role with responsibility for computer systems specifically LIMS, Empower, BMRAM, Chromeleon, environmental monitoring ... with Veeva QualityDocs /QMS is preferred.Knowledge and understanding of the FDA Computer Software Assurance (CSA) fundamental concepts.Basic understanding of… 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
- Merck & Co. (Rahway, NJ)
- …strategy.Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA ... of product design and development; manufacturing process development, qualification, and validation ; and design control and risk management techniques to positively… 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
- Cipla (Fall River, MA)
- …controlled documents to ensure compliance with GMP, GDP, and regulatory standards such as FDA 21 CFR Part 11, ICH, and ISO. This role supports the Quality Management ... System (QMS) by maintaining accurate, secure, and accessible documentation...approved and executed documents related to SOPs, batch records, validation and qualification protocols, specifications, training records, QMS related… more
- Twist BioScience (South San Francisco, CA)
- …software for laboratory instruments, interface with our Manufacturing Execution System (MES), and implement tools to streamline manufacturing workflows. This ... lab instrumentation and a passion for building reliable, scalable systems that empower high-throughput biotech manufacturing. Key Responsibilities:Design, implement,… more
- Cardinal Health (Augusta, ME)
- …solutions. You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment ... + Lead the design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who...In depth understanding and knowledge of successfully validating a computer system to meet all FDA ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… more
- Jabil (Hunt Valley, MD)
- …across cross-functional teams. This individual will be responsible for overseeing Computer System Validation (CSV) activities, ensuring compliance ... systems , and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation . +… more
- Jabil (Hunt Valley, MD)
- …the validation teams. + Provide oversight and strategic direction for the Computer System Validation (CSV) program and supervise CSV associates. Ensure ... activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process in compliance with global regulatory… more
- Zimmer Biomet (Austin, TX)
- …the Software Quality Assurance (SQA) strategy and execution for robotic medical device systems , ensuring compliance with applicable FDA and ISO regulations + You ... and compliance of software developed for medical device robotic systems , including embedded, cloud-based, and mobile applications. In this...Part 820, ISO 13485, IEC 62304, ISO 14971, and FDA guidance on software validation and cybersecurity… more
- Kelly Services (Bristol, TN)
- …new **LabVantage LIMS** , scheduled for go-live in late February/early March. + Oversee ** computer system validation ** (CSV) for LIMS, Waters Empower (HPLC), ... SAP interfaces, and other QC computerized systems . + Create and execute validation protocols...scientific, engineering, or related field. + Strong experience in computer system validation and/or process/equipment… more
- Medtronic (Juncos, PR)
- … documentation (URS, FAT/SAT, IQ/OQ/PQ, TMV, risk assessments). + Understanding of Computer System Validation (CSV) principles for integrated control ... systems , robotics, and digital factory technologies. + Ensure validation packages comply with FDA 21 CFR...The employee is also required to interact with a computer , and communicate with peers and co-workers. Contact your… more
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