Job-ID33084580Reference26-01742Summary : We are seeking a Senior Computer Systems Validation (CSV) Analyst with strong experience in GxP-regulated pharmaceutical/life sciences environments. The candidate will be responsible for planning, leading, and executing validation activities for SCADA, Rockwell FactoryTalk, PLCs, and Ignition process control systems. The role requires hands-on expertise in GAMP 5, 21 CFR Part 11, EU Annex 11, validation lifecycle documentation, risk assessments, change controls, and qualification protocols (IQ/OQ/PQ). The candidate will work closely with engineering, automation, quality, IT, and business teams to ensure systems remain compliant and validated.Roles & Responsibilities : Plan, lead, and execute CSV activities for SCADA, PLC, Rockwell FactoryTalk, and Ignition systems. Develop and review URS, FS, DS, Validation Plans, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and Summary Reports. Author and maintain documentation for GxP computerized systems. Apply GAMP 5 principles throughout the computer system validation lifecycle. Execute software/system validation test protocols and document results. Manage change controls for existing qualified systems. Assess system changes and determine validation impact. Prepare/revise validation documentation based on system changes. Ensure compliance with 21 CFR Part 11 and EU Annex 11. Manage deviations, issues, CAPAs, and validation discrepancies. Develop and execute test protocols and maintain proper evidence/documentation. Maintain project schedules and ensure validation deliverables are completed on time. Collaborate with Automation, Engineering, QA, IT, Manufacturing, and business stakeholders. Education & Experience : 5+ years of experience in Computer Systems Validation (CSV) within Life Sciences/Pharmaceutical/Biotech environments. Strong experience validating SCADA, PLC, Rockwell FactoryTalk, and/or Ignition systems. Hands-on experience with GAMP 5 and risk-based validation approaches. Strong knowledge of 21 CFR Part 11 and EU Annex 11. Experience with change control and system requalification. Experience managing deviations, issues, CAPAs, and corrective actions. Strong understanding of GxP computerized systems and regulated manufacturing environments. Excellent technical writing and documentation skills. Strong communication and project coordination skills.
...Century Group is partnering with a client who is seeking a Staff Accountant to join their team. Exact compensation may vary based on... ...accordance with state and local regulations. Qualifications: Bachelor's degree in accounting, finance, or related field preferred...
...Freight ForwarderLocation: Mendota Heights, USADivision: Air & SeaJob Posting Title: Freight ForwarderTime Type: Full TimeSummary: A Freight Forwarder is responsible for managing and coordinating the exportation of goods by air, including all necessary documentation,...
...Medical Records - Field Reviewer Altegra Health is a total solutions partner for healthcare data auditing and analytics. Altegra provides end-to... ...possible. We will also provide computer equipment for scanning charts and transferring files to our secure file transfer site....
...Nurse Practitioner | Neonatal Location: Panama City, FL Employer: VieMed Healthcare Staffing Pay: Competitive weekly pay (inquire for details) Start Date: ASAP About the Position Perm - Neonatal Nurse Practitioner - Panama City, FL | Level III...
...Job Description Job Description 1099 Installer for Window/Door Company in MO/IL Jacob Windows, Baths & Sunrooms JOB DETAILS Salary Potential $100k-$400k a year (Contractual Piece Work) Job Type Sub-Contractor Schedule Day Shift (Monday...