- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role: \tEngage on CSV Projects as a key team member. Provide guidance and support to ensure Insmed ... Develop risk-based validation strategies for system implementation and changes following CSV SOPs and Work Instructions Coordinate all validation activities with… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role: \tEngage on CSV Projects as a key team member. Provide guidance and support to ensure Insmed ... reviews.What You'll Do: Provide strategic leadership and decision making on CSV strategy using Insmed's risk-based approach. Provide oversight and manage multiple… more
- Insmed Incorporated (San Diego, CA)
- …to the following: Provide strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes ... following CSV SOPs and Work Instructions Coordinate all validation activities...activities with internal stakeholders and project team members. Author CSV Documents (Validation Plans and Summary Reports) Assist/co-author requirements,… more
- Formation Bio (New York, NY)
- …(GCP), Good Pharmacovigilance Practices (GPV) and Computer Systems Validation ( CSV ).The primary responsibilities for the Vice President of Quality Assurance ... and external partnership. Responsibilities Oversee GXP, Data Integrity, and CSV activities across various entities, investigator sites, research organizations,… more
- Cipla (Hauppauge, NY)
- …Support for Production, Warehouse and Quality Handling Audit Trails, CSV activities Network Administration, Software application management, Vendor management, User ... with Manufacturing, Packaging and WH IT solutions (MES/SCADA/LIMS etc.,), CSV activities with strong preference in pharmaceutical.Knowledge and experience in… more
- Insmed Incorporated (NJ)
- …oversee cybersecurity operations, enterprise risk management, and Computer Systems Validation ( CSV ) program. This role will manage cross-functional teams and ensure ... with validation of documentation, audit readiness, and continuous improvement of CSV processes. Risk Management: Define and implement risk management policies and… more
- Cipla (Fall River, MA)
- …Support for Production, Warehouse and Quality Handling Audit Trails, CSV activities Network Administration, Software application management, Vendor management, User ... with Manufacturing, Packaging and WH IT solutions (MES/SCADA/LIMS etc.,), CSV activities with strong preference in pharmaceutical. Knowledge and experience… more
- AUROBINDO (Durham, NC)
- …IT systems, laboratory instruments, and manufacturing equipment.ResponsibilitiesDevelop and execute CSV protocols (IQ, OQ, PQ) for GxP systems.Prepare Validation ... audit readiness and respond to regulatory inspections.Train stakeholders on CSV requirements and best practices.Participate in risk assessments and impact… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …with the safety policies, quality systems, and cGMP requirements.May support CSV activities as needed.May support equipment qualification activities as needed.Drive ... (MES) design/development and validation is preferred.Experience with Computer System Validation ( CSV ) is a plus.Knowledge of cGMP regulations and FDA/EU guidance… more
- Syner-G BioPharma Group (Boston, MA)
- …cGMP, FMEA, and Risk Analysis required.Validation expertise in Equipment, CSV , Method, and Process.Protocol generation experience of automated production systems, ... and systems validation.Report writing experience for IQ, OQ, PQ, and CSV .Knowledge, Skills, and Abilities: Strong verbal and written communication skills and… more
- Insmed Incorporated (NJ)
- …objectivesCollaborate closely with cross-functional teams including Quality Assurance, IT, CSV , and Compliance departmentsEnsure that Disaster Recovery meets the ... requirements of the businessWho You Are:Bachelor's degree in Computer Science, Information Technology, or related field7+ years of experience in IT with specific focus on Compliance-related systemsTechnical knowledge of LMS applications, compliance business,… more
- Christus Health (Santa Fe, NM)
- …guidance of the RN/ Nurse Leader with assigned patients, in accordance with CSV hospital guidelines for patient care. The Nurse Extern collaborates with other ... disciplines to achieve overall healthcare goals and is responsible for adhering to the patient plan of care in order to assist patient processes and outcomes. The Nurse Extern is responsible for competent care of patients in the hospital setting under the… more
- Christus Health (Santa Fe, NM)
- …ventilated smoke-free environment. PHYSICAL REQUIREMENTS: Ability to move throughout CSV facilities and to all hospital units/departments. Extensive use of ... a computer for required applications. Requires close work, good vision, and dexterity to write as well as type. xrbllit Requires the ability to speak, listen, develop, and communicate written materials. more
- Christus Health (Santa Fe, NM)
- …minimum 2 years with CSFA certification NATURE OF SUPERVISION: -Responsible to: CSV surgical services ENVIRONMENT: Bloodborne pathogen: C Employee will be instructed ... in Universal Precautions and Right to Know. Employee will be expected to utilize all protective equipment available whenever there is a potential for exposure to infectious materials or hazardous chemicals. Cleaning, repair and replacement of this protective… more
- Catalent Pharma Solutions (Kansas City, MO)
- **Senior Validation Specialist I, BioAnalytics Computer System Validation ( CSV ) & Compliance** **Position Summary:** Catalent, Inc. is a leading global contract ... City, MO (KCM) is hiring a Senior Validation Specialist I, BioAnalytics CSV & Compliance. The Senior Validation Specialist is primarily responsible for leading,… more
- Curia (Albany, NY)
- CSV Systems Engineer II/III in Albany, NY Level...our work has the power to save lives. The CSV Systems Engineer will be responsible for supporting Quality ... provide guidance and expertise on various global and site CSV projects to ensure that quality teams have the...Computer Systems Validation + Manage multiple site and global CSV projects at any time + Maintain close communication… more
- Lilly (Lebanon, IN)
- …operating areas across site and/or for capital projects. This role will provide CSV support leading and executing CSV activities for process automation systems ... change control and deviation management as it pertains to CSV activities * Collaborate with vendors to ensure that...audits as needed * Provide training to personnel on CSV principles, procedures and best practices * Stay informed… more
- J&J Family of Companies (Raritan, NJ)
- …is recruiting for an **Enterprise Quality R&D Clinical Computer System Validation ( CSV ) Manager** , located in either **Horsham, PA; Raritan, NJ; Beerse, Belgium** ... J&J's Systems Development Life Cycle (SDLC) and Computer System Validation ( CSV ) Framework, assuring compliance across the enterprise with applicable global… more
- Bristol Myers Squibb (Summit, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The Manager, CSV Equipment and Instrumentation - Cell Therapy supports the successful ... trust and collaborative relationships outside the immediate organization. The Manager, CSV Equipment and Instrumentation - Cell Therapy , through hands-on… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Automation Engineer 2, CSV will provide support to the Drug Substance Manufacturing (DSM) facility. This includes preparing validation ... Participates in the development of documents, processes, and procedures of the CSV program + Generates, reviews, and approves DSM Automation Computerized Systems… more
