- Kedrion Biopharma (Melville, NY)
- …across automation and computer systems within a GMP production facility. Computer System Validation Specialist is responsible for managing, ... and clinicians in hematology, immunology, neurology, and transfusion medicine. **JOB SUMMARY** The Computer System Validation Specialist at Kedrion… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who we are? We are a French pharmaceutical industrial group, recognized for making affordable healthcare products ... completed by an external company, the computer systems validation (CSV) specialist will...In depth understanding and knowledge of successfully validating a computer system to meet all FDA and… more
- Lilly (Indianapolis, IN)
- …Sciences & Quality Control Operations (AQCO) organization is seeking a Computer Systems Validation (CSV) Specialist to be responsible for qualifying and ... activities. + Validation Testing: + Perform validation testing for computer systems ...problem-solving skills. + Expertise with laboratory instrument qualification and Computer System Validation . + Ability… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- We are seeking a highly skilled, self-motivated **Senior Validation Specialist - CSV** to ensure compliance of computerized systems with regulatory ... 11, GAMP 5, and Annex 11. **As a Senior Validation Specialist , a typical day might include:**... validation documentation and explanations and communicates company's computer validation policies. + Generating, reviewing, editing,… more
- Novo Nordisk (Petersburg, VA)
- …and help us make what matters. The Position Plan, manage & performing laboratory validation activities on computer software systems . This role will also ... protocols preferred + Experience in managing projects preferred + Experience with electronic validation systems (TIMS) and SAP PM and QM module a plus + Working… more
- VTI Life Sciences (San Diego, CA)
- …companies in the Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that ... Test Scripts. + 3+ years of proven experience with SQL, Software Validation and Computerized Systems Validation . + Must have experience working in an… more
- Curia (Rensselaer, NY)
- …protocols and master plans, supervises validation activities such process/ equipment/ cleaning/ computer system validation etc. + Review and approve lab ... Senior Quality Assurance Validation Specialist in Rensselaer, NY Build...special projects as directed by management + Perform the computer system periodic reviews in coordination with… more
- Regeneron Pharmaceuticals (Troy, NY)
- … Specialist would also plan, coordinate and participate in compliant computer system validation (CSV) process for systems which require formal ... 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
- Boehringer Ingelheim (St. Joseph, MO)
- …staff and other departments. + Leads and actively supports strategic direction of validation philosophies, improve overall validation system and process flow ... office application software (MS-Word, MS-Excel, MS-Outlook, PowerPoint). **Requirements for a Sr. Specialist Validation ** + A BS degree from an accredited… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Approach depending on process and technical risks Proactive and consultative engagement of the Computer System Validation role within agile projects 2. Guide ... framework by conducting self-developed, process adapted training. Give active feedback into the Computer System Validation (CSV, Management System Owner… more
- PCI Pharma Services (Philadelphia, PA)
- …and execution of validation protocols for process, equipment, cleaning, and/or computer systems in the pharmaceutical and/or medical device industry. Strong ... across our global network to pioneer and shape the future of PCI. Job Title: Validation Specialist Summary of Objective: The Validation Specialist plays… more
- Fujifilm (College Station, TX)
- … cGMP regulations and practices pertaining to computer validation principles, manufacturing processes, quality systems , engineering design fundamentals, ... **Position Overview** The QA Specialist III, QA Validation , will be...in Pharmaceutical or other regulated Industry. + Experience with qualification/ computer validation experience. + Experience with qualification/… more
- Catalent Pharma Solutions (St. Petersburg, FL)
- …vessels, clean-in place systems , and parts washers. The **Senior Cleaning Validation Specialist ** also responsible for supporting the design, execution and ... **Senior Cleaning Validation Specialist ** **Position Summary** Catalent, Inc....department is responsible for ensuring that all facilities, processes, equipment/ systems and automated equipment used for GMP/GLP critical purposes… more
- Actalent (Clayton, NC)
- Validation Specialist Job Description As a Validation Specialist , you will perform revalidation on equipment and processes according to approved ... timelines. You will support validation activities related to changes... activities related to changes in existing and new systems , including formulation, sterilization, cleaning, filling, and inspection processes.… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …to reliably deliver benefits for patients worldwide. Position Summary As a Senior Specialist , Validation Services, you will play a key role in supporting ... test plans, and regulatory guidelines. + Proficiency in troubleshooting equipment and systems during validation activities. + Ability to manage multiple… more
- Merck (Rahway, NJ)
- …Experience supporting internal and external quality audits + Experience in instrument computer system validation \#eligibleforERP \#AR&D Current Employees ... department of our company's Research Laboratories Division is seeking applicants for a Validation Specialist position available at either the Rahway, New Jersey… more
- United Therapeutics (Silver Spring, MD)
- …an engineering degree will still be considered; however, the job title will be as a Validation Specialist ) + 8+ years of relevant validation experience in a ... Datalogger Software (preferably Amphenol / Ellab) + Ability to perform validation activities for equipment, process and/or computer -related validation … more
- Kelly Services (West Point, PA)
- …and/or communicate with the vendor/service engineer to identify resolutions. + Participate in computer system validation activities associated with new or ... **Instrument Validation Specialist ** **Key Responsibilities:** + Manage...participating in the validation of computerized laboratory systems or instruments (eg, system Installation and… more
- Actalent (Clayton, NC)
- Our client, an expanding biopharmaceutical company, is seeking a Validation Specialist to join their team. They will primarily be responsible for performing ... or more core validation areas (sterilization, cleaning, process or computer validation ) preferred. Experience in cGMP documentation practices & regulations… more
- Novo Nordisk (Durham, NC)
- …one or more core validation areas (equipment, cleaning, process, or computer validation ) preferred + Experience in cGMP documentation practices & regulations ... what matters. The Position Coordinate & drive implementation of science & risk-based validation . The incumbent will provide input to project team members through all… more