- Cardinal Health (Augusta, ME)
- …solutions. You will develop and deploy software code and solutions that comply with FDA computer systems validation methodology. The Medical Segment ... + Lead the design, development, and deployment of software solutions aligned with FDA computer systems validation (CSV) methodologies. + Define technical… more
- NTT DATA North America (Pittsburgh, PA)
- …business workflows. Experienced in delivering projects in regulated environments, ensuring compliance with FDA Computer Systems Validation (CSV) and ... of experience managing projects involving ERP, CRM, EDW, MDM, and eBusiness systems . Strong understanding of system integration, data migration, and application… more
- Unither Pharmaceuticals (Rochester, NY)
- Computer Systems Validation Specialist Who...In depth understanding and knowledge of successfully validating a computer system to meet all FDA ... recertifications, and recertification of sterile processes. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: Computer Systems Validation Activities (50%) Reviews… more
- Astellas Pharma (Westborough, MA)
- **Principal Computer System Validation Specialist** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? ... programs. AIRM is headquartered in Massachusetts. Astellas is announcing a **Principal Computer System Validation Specialist** opportunity at their… more
- West Pharmaceutical Services (Exton, PA)
- Senior Specialist, Computer System Validation Requisition ID: 71527 Date: Nov 1, 2025 Location: Exton, Pennsylvania, US Department: Laboratory Description: ... and leading the documentation for equipment that requires a computer system validation approach. You...with the industry standard practices and Global regulatory requirements ( FDA , EU) for computer systems ,… more
- Bristol Myers Squibb (Devens, MA)
- …personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The Senior Engineer, IT Computer System Validation , Cell Therapy Devens role will ... accordingly. + High quality assurance mindset with Quality Assurance experience in the computer system and pharmaceutical computerized systems field and… 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
- 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
- Zimmer Biomet (Austin, TX)
- …the Software Quality Assurance (SQA) strategy and execution for robotic medical device systems , ensuring compliance with applicable FDA and ISO regulations + You ... and compliance of software developed for medical device robotic systems , including embedded, cloud-based, and mobile applications. In this...Part 820, ISO 13485, IEC 62304, ISO 14971, and FDA guidance on software validation and cybersecurity… 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 ... Specialist is primarily responsible for leading, implementing and managing Computer System Validation (CSV) and...and Regulatory Compliance. Familiarity with cGMPs, ISPE GAMP5, fundamental validation practices and the following FDA and… more
- Cognizant (Boston, MA)
- …or life sciences domain, including 2+ years in a management role. + Expertise in Computer System Validation (CSV) and Computer Software Assurance (CSA). ... Lead** , you will make an impact by leading validation and testing initiatives across life sciences systems...this role, you will:** + Develop and implement comprehensive validation and test strategies aligned with FDA ,… more
- Endo International (St. Louis, MO)
- …and review. The position will also have responsibilities for the review/approval of validation activities for enterprise computer system software and other ... as needed to support the Specialty Generics organization. Software systems may be local or hosted solutions. The candidate...at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation … more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …and review. The position will also have responsibilities for the review/approval of validation activities for enterprise computer system software and other ... as needed to support the Specialty Generics organization. Software systems may be local or hosted solutions. The candidate...at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation … more
- Curia (Albuquerque, NM)
- …equipment and manufacturing process protocols and final report. + Review and approve validation protocols for computer related systems (as needed), ... validation protocols for processes, equipment, utilities, and test systems . The role also supports new product introductions, equipment...the review of changes made under the Change Control System from a validation perspective + Provide… more
- NTT DATA North America (Dallas, TX)
- …Responsibilities Test Strategy & Planning + Develop the overall testing and validation strategy, covering unit testing, system integration testing (SIT), ... for future SAP projects. Required Qualifications + Bachelor's degree in Information Systems , Computer Science, Engineering, or Business Administration. + 8 -… more
- Curia (Albuquerque, NM)
- …on the GAMP V-Model Framework, as well as EU GMP Annex 11 for computer systems compliance Supervisory Responsibilities: This role does not have supervisory ... Analyst II is responsible for executing and supporting validation activities for equipment, processes, utilities, systems ,...supervision: + Small projects: 1-2 test scripts, a single system or piece of equipment, one end customer, duration… more
- Cognizant (Boston, MA)
- … validation to guarantee seamless integration across platforms. . Coordinate Computer System Validation (CSV) activities to ensure compliance ... , you will make an impact by driving the validation strategy and execution for Document Management Systems...Deep knowledge of GxP regulations and global compliance standards ( FDA , EMA, MHRA, 21 CFR Part 11, Annex 11,… more
- Cognizant (Boston, MA)
- … to guarantee seamless integration across platforms and systems . + Manage Computer System Validation (CSV) activities in alignment with global regulatory ... will make an impact by leading the testing and validation strategy for enterprise-level Document Management Systems ...standards ( FDA , EMA, MHRA). + Utilize ALM tools to streamline… more
- Danaher Corporation (Chaska, MN)
- …+ Knowledge of FDA regulations, ISO standards, and GxP guidelines. + Experience with Computer System Validation (CSV) and process validation It would ... 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
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