- 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
- Jabil (Hunt Valley, MD)
- …across cross-functional teams. This individual will be responsible for overseeing Computer System Validation (CSV) activities, ensuring compliance ... systems , and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation . +… more
- Lilly (Pleasant Prairie, WI)
- …application of data management and integrity principles in operational processes, and Computer System Validation methodologies to ensure regulatory ... data management and integrity principles in operational processes, and Computer System Validation methodologies to...both locally and across global M&Q. Act as the Computer systems validation quality assurance… more
- PCI Pharma Services (Rockford, IL)
- …instrument configuration, and fundamentals of heating, air conditioning, and refrigeration systems . ** Computer Validation Focus:** _Associate's Degree in ... protocols, validation statements, reports, summaries, and master validation plans for new customer/product/ system project launch... computer tasks and have some experience with computer systems considered to have an impact… more
- US Tech Solutions (Thousand Oaks, CA)
- …adherence to computer validation standards and procedures for computer related systems . Responsibilities include participation in system design, ... 12 months contract** **Job Description:** Experience needed: Cold Storage Validation Experience Analytical Equipment experience Preferably Lab Ops/Equipment Background… more
- System One (Princeton, NJ)
- …Lead Validation Specialist with a strong background in clinical systems and computer systems validation to join our growing team. In this role, ... degree required. + 8+ years of professional experience in computer systems validation within life...pharmaceutical environment. + Familiarity with cloud technologies and web-based systems . System One, and its subsidiaries including… more
- Jabil (Hunt Valley, MD)
- …the validation teams. + Provide oversight and strategic direction for the Computer System Validation (CSV) program and supervise CSV associates. Ensure ... activities, including validation of facilities, utilities, equipment, cleaning, computer systems and process in compliance with global regulatory… more
- Takeda Pharmaceuticals (Thousand Oaks, CA)
- …with systems like LIMS, MES, ERP, SCADA, or DCS (eg, Delta V) for computer systems validation engineers. + Advanced knowledge of equipment, systems , ... matrices, and validation master plans. + Develop validation protocols (IQ/OQ/PQ) for computer systems...to define validation approaches and execution of system validation activities in accordance with cGMP… 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 ... Validation Specialist is primarily responsible for leading, implementing and managing Computer System Validation (CSV) and Data Integrity Programs (DI),… more
- Genentech (Hillsboro, OR)
- …(QC) team! We are looking to add a QC Validation Engineer with computer system validation or equipment qualification experience to our Quality Control ... regulated environment + You possess a deep understanding of equipment and/or computer system validation practices, regulations, and industry guidelines… more
- Kelly Services (Bristol, TN)
- …new **LabVantage LIMS** , scheduled for go-live in late February/early March. + Oversee ** computer system validation ** (CSV) for LIMS, Waters Empower (HPLC), ... SAP interfaces, and other QC computerized systems . + Create and execute validation protocols...scientific, engineering, or related field. + Strong experience in computer system validation and/or process/equipment… more
- ThermoFisher Scientific (Santa Clara, CA)
- …systems such as **DeltaV** , PLC/SCADA, or similar platforms. + Experience implementing ** Computer System Validation (CSV)** programs and using digital ... global health and innovation. **What will you do?** + **Lead and define validation strategies** for TruBio software and bioprocessing systems , aligning 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 ... 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
- ThermoFisher Scientific (Frederick, MD)
- …food or pharmaceutical packaging or cGMP experience **Minimum Qualifications:** + Knowledge of Computer System Validation (CSV) + Knowledge of Controlled ... will be responsible to interact with several departments to provide validation support for computer systems , equipment and processes, along with the critical… more
- Capgemini (Chicago, IL)
- …the job you're considering** We are seeking a Validation Lead to drive Computer System Validation (CSV) initiatives **Work Arrangement: On-site at client ... meets Good Documentation Practices (GDP) **Your skills and experience** + Computer System Validation (CSV) expertise, including hands‑on IQ/OQ/PQ execution… more
- ThermoFisher Scientific (Allentown, PA)
- …in a safe and efficient manner **Knowledge, Skills, Abilities** + Knowledge of Computer System Validation (CSV) + Knowledge of Controlled Temperature ... will be tasked with interacting with several departments to provide validation support for computer systems , equipment and processes, along with the critical… more
- Danaher Corporation (Chaska, MN)
- …+ Knowledge of FDA regulations, ISO standards, and GxP guidelines. + Experience with Computer System Validation (CSV) and process validation It ... one million tests are run on Beckman Coulter Diagnostics systems , impacting 1.2 billion patients and more than three...system ) which makes everything possible. The Senior QA Validation Engineer is responsible for assisting in the sustainment… more
- PACIV (Indianapolis, IN)
- …protocols, and final reports. + Proficient in Commissioning & Qualification (C&Q) and/or Computer System Validation (CSV), with a solid understanding of ... and utilities sectors, specializing in delivering compliant, high-performance automation systems tailored to regulated environments. Join our Indianapolis, IN team… more
- PACIV (Indianapolis, IN)
- …completion action items for any deficiencies resulting from Periodic Reviews. + Update Computer System Validation (CSV) documentation which may include ... environment. This role is responsible for executing and managing periodic reviews of computer systems , and driving resulting action items to completion.. The… more
- Quality Consulting Group (Villalba, PR)
- … systems on existing work instructions and processes. + Prepare and execute computer system validation protocols and generate comprehensive reports. + ... of experience + Practical knowledge and demonstrated competence in validation and quality systems + Investigation and...writing knowledge + Organization and Communication skills + Process Validation and Computer software validation … more