| Looking for Sr. Validation Engineer at Marion, North Carolina, USA |
| Email: [email protected] |
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http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=3472378&uid=678c5f1096a1477789efac645c67eac8 From: ajeet, gvrinfotek [email protected] Reply to: [email protected] Job Description - Sr. Validation Engineer Location - Hybrid, 65 Pitts Station Road Marion NC 28752 United States (Local preferred, reloc is okay on own expenses) Duration: 12+months Mode of Interview:Skype MUST HAVE EXPERINECE WITH KNEAT Gx Role Overview The Validation Specialist Contract will support pharmaceutical and medical device operations by executing and maintaining compliant validation activities using Kneat Gx as the electronic validation lifecycle management system. This role is focused on hands on execution of validation deliverables to support equipment process utility and computerized system readiness in accordance with FDA ISO and cGMP requirements. The specialist will work closely with Engineering Quality Automation IT and Operations to ensure systems and equipment are validated audit ready and capable of supporting safe compliant production. Key Responsibilities Validation Execution Primary Role - Execute IQ OQ PQ requalification and validation maintenance activities for pharma and medical device manufacturing systems. - Support validation of: o Manufacturing and packaging equipment o Utilities compressed air clean utilities environmental controls o Computerized systems automation data acquisition MES LIMS vision systems - Apply risk based validation methodologies aligned with GAMP 5 and industry best practices. KNEAT Gx Lifecycle Management - Author execute review and route validation documents within KNEAT Gx. - Maintain end to end traceability between: o User Requirements URS o Risk Assessments o Test cases and protocols o Deviations and final reports - Ensure proper use of KNEAT Gx workflows execution controls and electronic approvals. - Maintain compliance with 21 CFR Part 11 and data integrity expectations. Deviation Change Control CAPA Support - Document and investigate validation deviations within KNEAT Gx. - Support change control impact assessments affecting validated systems. - Participate in root cause analysis and CAPA implementation when required. Regulatory Quality Compliance - Ensure validation deliverables comply with: o FDA cGMP regulations 21 CFR Parts 210/211 Part 11 o ISO 13485 Medical Devices o Internal Quality Management System QMS requirements - Support regulatory inspections and customer audits by providing validation documentation and responses. - Maintain validation documentation in a state of continuous inspection readiness. Cross Functional Support - Collaborate with Engineering Quality IT Automation Manufacturing and external vendors. - Provide on floor support during commissioning troubleshooting and validation execution. - Support site initiatives such as new equipment introduction line upgrades remediation efforts and capacity expansions. Preferred Qualifications - Experience supporting medical device manufacturing under ISO 13485. - Experience with automation and controls PLC/SCADA vision systems or MES. - Experience supporting high speed packaging or assembly lines. - Exposure to validation remediation or regulatory commitment work. Core Competencies - Detail oriented with a strong compliance mindset - Ability to work independently under contract deliverables - Strong problem solving and root cause analysis skills - Effective communication with cross functional teams - Comfortable working in production and controlled environments Keywords: information technology North Carolina Looking for Sr. Validation Engineer [email protected] http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=3472378&uid=678c5f1096a1477789efac645c67eac8 |
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| 04:34 AM 24-Jun-26 |