Job-ID32575457Reference26-01231Remote50% Remote Job Description: We are seeking a Computer System Validation (CSV) Engineer for a global pharmaceutical client. This role will work cross-functionally to lead and execute validation activities for GxP electronic systems and applications. The CSV Engineer will partner with Business Owners, Technical Owners, and Quality teams to create and manage validation deliverables throughout the validation lifecycle. The primary responsibility is to ensure that validation activities supporting Manufacturing Execution Systems (MES) are documented in accordance with applicable procedures and regulatory requirements. Roles & Responsibilities: Author, review, and/or approve applicable CSV documentation. Assist Business Owners and Technical Owners during test execution, document test failures, and ensure testing aligns with internal procedures. Assist Business Owners and Technical Owners in developing requirements and specifications for computerized systems used in GxP operations. Support validation activities for Manufacturing Execution Systems (MES). Develop and maintain CSV documentation including Validation Plans, Requirements, Specifications, Assessments, Test Scripts (IQ/OQ/PQ or equivalent), Summary Reports, Trace Matrices, and SOPs. Ensure compliance with cGMP, GxP, GAMP, SDLC regulations, 21 CFR Part 11, and Good Documentation Practices. Support validation of pharmaceutical manufacturing and laboratory systems used in biologics and clinical manufacturing environments. Utilize IT service management platforms to support incident, problem, and change management activities. Work with Business Quality Management Systems and related validation processes. Requirements: Bachelor's degree in Life Sciences, Engineering, IT, or a related discipline, or equivalent industry experience. Minimum 4+ years of direct experience in Computer System Validation (CSV). Strong knowledge of GAMP and risk-based validation approaches. Good understanding of electronic records and electronic signatures. Strong knowledge of Manufacturing Execution System (MES) validation. Familiarity with MES systems such as Emerson Syncade, ERP systems such as SAP or Oracle, and EBR systems such as InfoBatch. Strong experience developing CSV documentation, including Validation Plans, Requirements, Specifications, Assessments, Test Scripts, Summary Reports, Trace Matrices, and SOPs. Knowledge of pharmaceutical, manufacturing, and laboratory systems supporting biologics and clinical manufacturing. Experience with IT service management platforms such as ServiceNow. Exposure to Business Quality Management Systems such as Veeva.
...KAG Energy, a division of Kenan Advantage Group, is currently hiring Owner Operator Truck Drivers in your area! Join KAG today to take advantage of great pay, competitive benefits packages, supportive terminal managers and great equipment! Currently hiring Owner...
...accommodation or an alternative application process. Sports Massage Therapist & Deep Tissue Full Time Spa Innisbrook Resort, Palm... ...exceptional customer service while providing professional massage and body treatments. ESSENTIAL JOB FUNCTIONS Understands and...
...create and implement the most advanced training and technology the transportation industry... ...School Bus Drivers in Albany, NY; No Experience Necessary! We Train! Your day will include... ...agreement, Starting Pay - $29/HR Paid CDL Training Additional Hours Available -...
...as specialty trade commercial contractors servicing the construction industry. Bonitz designs and installs custom flooring, walls, ceilings, and cladding systems. We offer access, terrazzo and other specialty flooring as well as floor care. We are committed to providing...
...Gondola is seeking a dedicated Social Media Intern for the 2026 Summer season at the Fargo-Moorhead RedHawks. This role focuses on creating... ...for the team's social media channels, updating fans during games, and contributing to various communications tasks. The ideal candidate...