Katalyst CRO
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Validation Engineer III
role at
Katalyst CRO Continue with Google Continue with Google 6 months ago Be among the first 25 applicants Join to apply for the
Validation Engineer III
role at
Katalyst CRO QAV Documentation Review and Approvals for local and CMO's. CS Periodic Reviews planning and approvals. QA GMP IT Support for DI and CS INF activities. Validation and Metrology QMS events ownership as QAV (Change Control, CAPA & Deviation). QRFR's Generation. Metrology Deliverables Review & Approval (forms or SOP's) + SAP Operation. SME support on the GMP Equipment Calibration/ PM/ Breakdown assessment from QAV Technical perspective. Validated Equipment Requalification, Modification/ Remediation/ Decommissioning. Software Upgrade(s). Validation SME support for QMS Impact Assessments and Change Actions. Validation Support for Risk Assessment on Equipment. AdHOC Validation Support on Global Computerized Equipment Deployment. Serve as liaison and cross-functional lead with department likes QC, Manufacturing and Quality Assurance to provide an overall compliant Validation and QAV program with Client standards and GMP regulations. The role will support the Validation, Metrology and QAV department in drafting, reviewing, approving documentation in conjunction with Client guidelines. URS. Registration/ Calibration form. SCCA forms. Risk Assessment (for equipment with CSV). Configuration Spec. (for equipment with CSV or as applicable). Global/Digital CS System QAV Representation and deliverables approver. Internal Validation protocol. Requirements Traceability Matrix. Internal Final Report. Reports will be provided within client Quality Management System and email. Reports to channel through Quality Assurance Validation staff.
Responsibilities
Local Validation Program Maintenance. QAV Documentation Review and Approvals for local and CMO's. CS Periodic Reviews planning and approvals. QA GMP IT Support for DI and CS INF activities. Validation and Metrology QMS events ownership as QAV (Change Control, CAPA & Deviation). QRFR's Generation. Metrology Deliverables Review & Approval (forms or SOP's) + SAP Operation. SME support on the GMP Equipment Calibration/ PM/ Breakdown assessment from QAV Technical perspective. Validated Equipment Requalification, Modification/ Remediation/ Decommissioning. Software Upgrade(s). Validation SME support for QMS Impact Assessments and Change Actions. Validation Support for Risk Assessment on Equipment. AdHOC Validation Support on Global Computerized Equipment Deployment. Serve as liaison and cross-functional lead with department likes QC, Manufacturing and Quality Assurance to provide an overall compliant Validation and QAV program with Client standards and GMP regulations. The role will support the Validation, Metrology and QAV department in drafting, reviewing, approving documentation in conjunction with Client guidelines. URS. Registration/ Calibration form. SCCA forms. Risk Assessment (for equipment with CSV). Configuration Spec. (for equipment with CSV or as applicable). Vendor qualification package (if purchased). Global/Digital CS System QAV Representation and deliverables approver. Internal Validation protocol. Requirements Traceability Matrix. Internal Final Report. Reports will be provided within client Quality Management System and email. Reports to channel through Quality Assurance Validation staff.
Requirements:
Engineer or related BSc/BEng degree. Previous Pharma Experience required. Previous QA Validation experience Required. Minimum 10-15 years of experience. Previous experience supporting a Business System Owners on their GMP Manufacturing and Lab Equipment as well as supporting Corporate/Global Computerized Systems and manufacturing. Previous experience QAV department in drafting, reviewing, approving documentation. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Validation Engineer jobs in
Waltham, MA . QA Specialist II, Validation, Contractor
Lowell, MA $80,000.00 - $100,000.00 1 week ago Boston, MA $72,800.00 - $80,100.00 6 days ago Cambridge, MA $97,440.00 - $155,904.00 7 hours ago Westborough, MA $125,000.00 - $140,000.00 13 hours ago Massachusetts, United States 11 hours ago Cambridge, MA $97,440.00 - $155,904.00 9 hours ago Marlborough, MA $79,700.00 - $151,400.00 1 day ago Massachusetts, United States $65 - $70 3 weeks ago Senior Quality Engineer (including machined parts)
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
Validation Engineer III
role at
Katalyst CRO Continue with Google Continue with Google 6 months ago Be among the first 25 applicants Join to apply for the
Validation Engineer III
role at
Katalyst CRO QAV Documentation Review and Approvals for local and CMO's. CS Periodic Reviews planning and approvals. QA GMP IT Support for DI and CS INF activities. Validation and Metrology QMS events ownership as QAV (Change Control, CAPA & Deviation). QRFR's Generation. Metrology Deliverables Review & Approval (forms or SOP's) + SAP Operation. SME support on the GMP Equipment Calibration/ PM/ Breakdown assessment from QAV Technical perspective. Validated Equipment Requalification, Modification/ Remediation/ Decommissioning. Software Upgrade(s). Validation SME support for QMS Impact Assessments and Change Actions. Validation Support for Risk Assessment on Equipment. AdHOC Validation Support on Global Computerized Equipment Deployment. Serve as liaison and cross-functional lead with department likes QC, Manufacturing and Quality Assurance to provide an overall compliant Validation and QAV program with Client standards and GMP regulations. The role will support the Validation, Metrology and QAV department in drafting, reviewing, approving documentation in conjunction with Client guidelines. URS. Registration/ Calibration form. SCCA forms. Risk Assessment (for equipment with CSV). Configuration Spec. (for equipment with CSV or as applicable). Global/Digital CS System QAV Representation and deliverables approver. Internal Validation protocol. Requirements Traceability Matrix. Internal Final Report. Reports will be provided within client Quality Management System and email. Reports to channel through Quality Assurance Validation staff.
Responsibilities
Local Validation Program Maintenance. QAV Documentation Review and Approvals for local and CMO's. CS Periodic Reviews planning and approvals. QA GMP IT Support for DI and CS INF activities. Validation and Metrology QMS events ownership as QAV (Change Control, CAPA & Deviation). QRFR's Generation. Metrology Deliverables Review & Approval (forms or SOP's) + SAP Operation. SME support on the GMP Equipment Calibration/ PM/ Breakdown assessment from QAV Technical perspective. Validated Equipment Requalification, Modification/ Remediation/ Decommissioning. Software Upgrade(s). Validation SME support for QMS Impact Assessments and Change Actions. Validation Support for Risk Assessment on Equipment. AdHOC Validation Support on Global Computerized Equipment Deployment. Serve as liaison and cross-functional lead with department likes QC, Manufacturing and Quality Assurance to provide an overall compliant Validation and QAV program with Client standards and GMP regulations. The role will support the Validation, Metrology and QAV department in drafting, reviewing, approving documentation in conjunction with Client guidelines. URS. Registration/ Calibration form. SCCA forms. Risk Assessment (for equipment with CSV). Configuration Spec. (for equipment with CSV or as applicable). Vendor qualification package (if purchased). Global/Digital CS System QAV Representation and deliverables approver. Internal Validation protocol. Requirements Traceability Matrix. Internal Final Report. Reports will be provided within client Quality Management System and email. Reports to channel through Quality Assurance Validation staff.
Requirements:
Engineer or related BSc/BEng degree. Previous Pharma Experience required. Previous QA Validation experience Required. Minimum 10-15 years of experience. Previous experience supporting a Business System Owners on their GMP Manufacturing and Lab Equipment as well as supporting Corporate/Global Computerized Systems and manufacturing. Previous experience QAV department in drafting, reviewing, approving documentation. Seniority level
Seniority level
Mid-Senior level Employment type
Employment type
Contract Job function
Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Katalyst CRO by 2x Get notified about new Validation Engineer jobs in
Waltham, MA . QA Specialist II, Validation, Contractor
Lowell, MA $80,000.00 - $100,000.00 1 week ago Boston, MA $72,800.00 - $80,100.00 6 days ago Cambridge, MA $97,440.00 - $155,904.00 7 hours ago Westborough, MA $125,000.00 - $140,000.00 13 hours ago Massachusetts, United States 11 hours ago Cambridge, MA $97,440.00 - $155,904.00 9 hours ago Marlborough, MA $79,700.00 - $151,400.00 1 day ago Massachusetts, United States $65 - $70 3 weeks ago Senior Quality Engineer (including machined parts)
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr