- 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
- 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
- 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
- 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 ... SaMD products are in accordance with internal SOPs, Quality System Requirements which include ISO 13485, FDA ...development and validation practices comply with Caris's Computer System Validation Process. +… 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
- Curia (Albuquerque, NM)
- …facilities, utilities, materials, products, computer systems , quality systems , regulatory submissions, calibration, and validation + Oversee the site's ... actions + Participate in on-site customer and regulatory agency inspections (eg, FDA , EMA, PMDA, CFDA), presenting quality systems information, and supporting… 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
- Integra LifeSciences (Princeton, NJ)
- …or more of the areas listed below. + Controlled environment monitoring + Water system monitoring + Bacterial endotoxin test method validation and monitoring + ... Bioburden test method validation and monitoring + Radiation sterilization validation and dose audit management + Ethylene oxide sterilization validation and… 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
- Novo Nordisk Inc. (Boulder, CO)
- …production. Routine interactions with analytical development for implementation and validation of analytical methods. Essential Functions Requires full-time, on-site ... QC laboratory Assist with implementation and integration LIMS and other Novo software systems as they relate to Quality Control Create and refine process and… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …have experience working within an aseptic manufacturing facility, preferably in training/ system applications, quality systems , or learning management systems ... training program for Operations (Manufacturing, Warehouse, Facilities & Engineering, Validation , Technical Support, Supply Chain) that supports daily clinical… more
- Ascensia Diabetes Care (Portsmouth, NH)
- …marketing, R&D organizations, customers and other plants. + Design and execute Validation and/or Qualification exercises in accordance with FDA General ... Onsite: Portsmouth, NH What you will be doing: + Design and execute Validation and/or Qualification exercises + Lead/Collaborate with internal and external Teams in… more
- Epredia (Portsmouth, NH)
- …marketing, R&D organizations, customers and other plants. + Design and execute Validation and/or Qualification exercises in accordance with FDA General ... Onsite: Portsmouth, NH What you will be doing: + Design and execute Validation and/or Qualification exercises + Lead/Collaborate with internal and external Teams in… more
Related Job Searches:
Computer,
Computer System,
Computer System Validation,
FDA,
System,
System Validation,
Validation