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.
...physically demanding job that requires constant lifting. Applicants must be able to repetitively lift 30-50 pounds.Shifts are Monday through Friday 9AM - end of shift. The shift ends when all work is complete.-$20.00 per hour during training period (estimated to be 6...
...Description Job Description PRIMARY FUNCTION This position is responsible for ensuring the safe and timely preparation of works of art for display, exhibition and transport. DUTIES AND RESPONSIBILITIES Installing and de-installing artwork in galleries and...
...Electronic Technician Department:RMA Operations Location:Oskaloosa, IA START YOUR PROFILE ( Electronic Technician The MuscoRMA Operations Teamhas an opening for anElectronic Technicianat ourOskaloosa office. In this position, you will perform troubleshooting...
...Concierge Under the direction of the Supervisor Front Desk, the Concierge consistently elevates guest satisfaction by delivering best... ...opportunity. Designs and coordinates experiences pertaining to dining, hotel, entertainment, transportation, and special event reservations,...
...Flik Hospitality Group Food Transporter/Delivery Driver We are hiring immediately for full time FOOD TRANSPORTER/DELIVERY DRIVER positions. Location: LA Rams - 1 Dole Drive, Westlake Village, CA 91362. Note: online applications accepted only. Schedule: Full time schedule...