- 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
- 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
- Catalent Pharma Solutions (Harmans, MD)
- …This position will provide continuous improvement support to process, equipment, utilities and computer systems and serve as the key Quality resource for the ... **Lead Specialist , QA Validation & Engineering** Catalent...completion in a Quality role. + Support the Computerized System Validation Lifecycle to ensure compliance to… 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
- 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
- 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
- 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
- Mentor Technical Group (Caguas, PR)
- …and quality of serialized products. Key Responsibilities: + Develop and execute validation protocols for serialization equipment, processes, and systems . + ... records for all validation activities. + Analyze validation test data to determine whether systems ...Required Skills and Qualifications: + Bachelor's degree in Engineering, Computer Science, or a related field. + Proven experience… more
- The Greentree Group (Madison, WI)
- Independent Verification & Validation (IV&V) Technical Specialist + A re you a technology enthusiast who loves solving complex problems? + Do you have a keen eye ... to hear from you! ABOUT THE OPPORTUNITY As a potential Independent Verification & Validation (IV&V) Technical Specialist , you will have the opportunity to work… more
- MTA (Brooklyn, NY)
- Computer Specialist Series Job ID: 10915...computer field and one year of satisfactory full-time computer software experience in computer systems ... Date Posted: Mar 17, 2025 Description Job Information Title: Computer Specialist Series First Date of Posting:...computer field and two years of satisfactory full-time computer software experience in computer systems… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are seeking a Building Automation System (BAS) Specialist to join our team responsible for coordinating and assisting with the design, installation, ... commissioning, startup and validation of new HVAC Building Automation System ...System (BAS) projects as well as updating current systems and documentation. We provide BAS technical and troubleshooting… more
- Integra LifeSciences (Princeton, NJ)
- …test scripts, URS documents, FRS and Configuration Specification documentation following Integra's Computer System Validation and Change control process to ... of Integra's Business Systems Team, the Quality Systems Senior Specialist is a seasoned professional...planning and in respect of internal processes for project computer systems validation and change… more
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