- Cytiva (Muskegon, MI)
- …Qualification (OQ), Performance Qualification (PQ), process validation (PV), cleaning validation (CV) and Computer Software Validation (CSV) protocols ... and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into...Engineer will be the subject matter expert for the validation strategy and maintain ownership of the Muskegon site… more
- Aldevron (Miami, FL)
- …preferred) and 4+ years of experience with automation, engineering, networking, or Computer System Validation required.Experience with either Allen Bradley, ... Siemens, or Emerson PLCs required.Experience with HMI design, SCADA, DCS, and/or site scale control strongly preferredBiologics GMP manufacturing and processing requirementsRegulatory requirements for biologics manufacturingJoin our winning team today.… more
- Raytheon (Tucson, AZ)
- …of CAS requirements, CAS architecture, requirements risk, requirements verification and validation , system performance & function, safety and environmental ... problems that create a safer, more secure world.The Precision Control Actuation System department is seeking a mechanical design engineer to join the… more
- Raytheon (Tewksbury, MA)
- …will have extensive experience in testing and validating radio frequency (RF) systems and components. You will be responsible for ensuring the performance, quality, ... from you.What Will You DoDevelop and execute comprehensive test plans for RF systems and components.Perform RF testing using advanced test equipment such as spectrum… more
- Kedrion Biopharma (Melville, NY)
- …automation and computer systems within a GMP production facility. Computer System Validation Specialist is responsible for managing, developing, and ... and clinicians in hematology, immunology, neurology, and transfusion medicine. **JOB SUMMARY** The Computer System Validation Specialist at Kedrion serves as… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …providing validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing, and approving ... **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the life sciences industry as a part… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist...In depth understanding and knowledge of successfully validating a computer system to meet all FDA and ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… more
- Catalent Pharma Solutions (Harmans, MD)
- **Senior Engineer, Computer Systems Validation ** **Position Summary:** Catalent, Inc. is a leading global contract development and manufacturing organization ... involved in processing steps related to equipment, facility/utility and computer systems validation . This role...to 21 CFR Part 11 compliance requirements and Global Computer System Validation and ISPE… more
- PCI Pharma Services (Bedford, NH)
- …/software/equipment. Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, ... skills. **EXPERIENCE** + At least 3+ years of relevant computer systems validation systems...(eg FDA, MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation … more
- Bristol Myers Squibb (Indianapolis, IN)
- …RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager, IT - GxP Computer Systems Validation & IT Process Lead is an integral part of ... and commercialization goals. **Job Responsibilities** + Manage and Deliver applicable risk-based Computer Systems Validation across RayzeBio Digital and IT… more
- Abeona (Cleveland, OH)
- Job Description JOB TITLE: Computer System Validation Engineer Department: Validation Reports to: Director of Validation As a Computer System ... production. Essential Duties and Responsibilities . Develop and execute validation deliverables for new and existing GxP systems...11, EU Annex 11, GAMP 5). . Partner with system owners, QA, IT, and vendors to define User… more
- Cognizant (Muskegon, MI)
- …engineering project work. The CSV Lead will have 10 plus years of experience of automation systems computer systems validation in a GMP environment. The ... Historian, MES, ABB as well as other DCS and OT systems . **Requirements** : The Validation Lead responsibilities include: Project master validation planning… more
- Catalent Pharma Solutions (Somerset, NJ)
- **INTERNET POSTING** ** ** **Job Title:** Manager Computer System Validation and Data Integrity **City:** Somerset **State** : NJ **JOB DESCRIPTION** : ... and compliance resource, bringing forth opportunities for the implementation of new world-class systems and leverage existing systems for the assurance of GMP… more
- Fujifilm (College Station, TX)
- … cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems , engineering design fundamentals, ... in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/ validation… more
- Novo Nordisk (Bloomington, IN)
- … validation + Understand other validation technical disciplines, such as cleaning, computer system validation , and process validation , and be able ... other validation technical disciplines, such as equipment validation , computer system validation...plans, protocols, and reports related to commissioning, qualification, and validation of simple systems and processes. This… more
- Takeda Pharmaceuticals (Libertyville, IL)
- …focus on disciplines related to equipment, cleaning, process, control system and computer system validation . **How you will contribute:** + Experience ... Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation , and Validation… more
- Regeneron Pharmaceuticals (Troy, NY)
- … Specialist would also plan, coordinate and participate in compliant computer system validation (CSV) process for systems which require formal ... a Principal QA Validation Specialist to support validation and qualification of computer systems...following: + Generates, executes and/or reviews master and completed computer system (s) qualification and validation … more
- Catalent Pharma Solutions (Harmans, MD)
- …and Global cGMPs relevant to 21 CFR Part 11 compliance requirements and Global Computer System Validation , USP Guidelines, ICH Guidelines, and ISPE GAMP ... a culture of ownership, technical excellence, and continuous improvement in equipment validation , metrology, and automation systems . + Contribute to site… more
- United Therapeutics (Silver Spring, MD)
- … Datalogger Software (preferably Amphenol / Ellab) + Ability to perform validation activities for equipment, process and/or computer -related validation ... by either overseeing or else providing hands-on assistance during testing to either System Owners or Validation management + Ability to interact and communicate… more
- Astellas Pharma (Sanford, NC)
- …coverage and flexibility may be required. **Preferred Qualifications** + Experience with computer verification/ validation . + Experience working in a clinical and ... **Specialist, QA Validation ** Do you want to be part of...responsible for the implementation, execution and assessment of quality systems , procedures, and records to support compliant GMP operations.… more
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