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.
...Job Title: React JS Developer Location: Any Altimetrik Location Contract Job Description We are looking for a skilled React JS Developer with strong frontend development experience to build scalable and high-performance web applications. The ideal...
...at any phase by providing industry-leading patient access, clinical trial management, and analysis across cardiology/nephrology,... ...the therapeutic pipeline. Position Summary: The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and conduct...
...Senior Healthcare Recruiter - Growth Opportunity Fremont, CA $260,000 - $1,325,000 a year Full Time Join a Transformative Team and... ...limits. Flexible Work Environment: Embrace the freedom of remote work. Your Ideal Profile ~2 to 3 years of experience...
...communication, the remote Adjunct Professor - Communication will teach courses in public speaking and general education, focusing on... ...curriculum development and instructional designProficiency with online teaching platforms and technologyCommitment to fostering an inclusive...
...Medical Scribe Medical Scribe Physician Documentation Specialist... ...the United States. You will work alongside our physicians ... ...experience in medical scribing, transcription, or healthcare administrative... ...internet Dedicated quiet home workspace with noise-...