Job-ID32540082Reference26-01147Remote50% Remote Job Summary:We are seeking an experienced Computer System Validation (CSV) Engineer/Contractor to lead and execute validation activities for GxP computerized systems, with a strong focus on Manufacturing Execution Systems (MES) in a pharmaceutical or biologics manufacturing environment.The ideal candidate will have expertise in CSV lifecycle management, GAMP, 21 CFR Part 11, protocol development and execution, and cross-functional collaboration to ensure compliance with regulatory and quality requirements.Roles & Responsibilities:Lead and execute Computer System Validation (CSV) activities for GxP computerized systems and applications throughout the validation lifecycle.Develop, review, execute, and maintain CSV documentation, including Validation Plans, User Requirements Specifications (URS), Functional/Design Specifications, Risk Assessments, IQ, OQ, PQ protocols, Traceability Matrices, Validation Summary Reports, and SOPs.Support the validation of Manufacturing Execution Systems (MES) and ensure compliance with internal procedures and regulatory requirements.Partner with Business Owners, Technical Owners, Quality Assurance (QA), Manufacturing, Engineering, and IT teams to develop validation deliverables and system requirements.Assist with User Acceptance Testing (UAT) by supporting protocol execution, documenting test results, investigating test failures, and ensuring testing complies with established procedures.Develop system requirements and specifications for computerized systems used in GxP manufacturing operations.Perform risk-based validation activities in accordance with GAMP methodology.Ensure compliance with cGMP, GxP, GAMP, SDLC, and 21 CFR Part 11 regulations governing computerized systems and electronic records.Support change control, incident management, and system lifecycle activities using IT service management tools.Collaborate with cross-functional teams to resolve validation issues and maintain audit-ready documentation.Provide on-site support throughout User Acceptance Testing (UAT) execution.Requirements / Qualifications:Bachelor's degree in Life Sciences, Engineering, Information Technology, Computer Science, or a related discipline (or equivalent industry experience).4+ years of experience in Computer System Validation (CSV) within a GxP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment.Strong hands-on experience with Manufacturing Execution Systems (MES) validation (e.g., Emerson Syncade).Strong understanding of Computer System Validation (CSV) principles and validation lifecycle activities.Experience developing and executing CSV documentation, including:Validation PlansUser Requirements Specifications (URS)Functional/Design SpecificationsRisk AssessmentsIQ/OQ/PQ ProtocolsValidation Summary ReportsTraceability MatricesStandard Operating Procedures (SOPs)Strong knowledge of GAMP 5, 21 CFR Part 11, cGMP, GxP, SDLC, and Good Documentation Practices (GDP).Experience with User Acceptance Testing (UAT), protocol drafting, execution, and defect management.Familiarity with ERP systems (e.g., SAP, Oracle) and Electronic Batch Records (EBR) systems (e.g., InfoBatch).Experience with Quality Management Systems (e.g., Veeva) and IT Service Management tools (e.g., ServiceNow).Knowledge of pharmaceutical manufacturing, laboratory systems, and biologics manufacturing processes.Excellent technical writing, communication, problem-solving, and cross-functional collaboration skills.Ability to work independently while managing multiple validation activities in a fast-paced, regulated environment.
...procedures, as well as portable and outpatient imaging across many hospital departments including surgery, critical care and our recently... .... These reasons can include changes of Legal Employer, FTE, Union, location, time-off plan policies, availability of health and welfare...
We are seeking an Import / Export Specialist to manage day-to-day international trade compliance and support inbound and outbound shipments across the organization. This role will be responsible for customs classification, documentation, broker coordination, regulatory...
...Quality Management Program Coordinator Plans, coordinates and implements the quality management and improvement programs for the hospital. Monitors and provides assistance with quality... ...Education: Bachelor's degree in nursing, Statistics, Healthcare, Business, or...
...quality food and environment for our guests, wewant to hear from you!DISHWASHER/GENERALUTILITY REQUIREMENTS: Must be at least 17 years oldEligible to work in the United StatesTeam-oriented with a passion to succeedOUR PRINCIPLES: Respect your team; treat them as you...
...AI agents for security weaknesses. It checks whether an application can be tricked into ignoring its instructions, leaking private data, or taking actions it shouldn't. Every finding is backed by recorded evidence. Teams use Aethel to know whether their AI is safe to...