Katalyst CRO
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CSV Validation Engineer
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Katalyst CRO 8 months ago Be among the first 25 applicants Join to apply for the
CSV Validation Engineer
role at
Katalyst CRO Our client is currently in the process of starting up a clinical cell therapy site with clean rooms. They are in the commissioning phase and validating documentation and processes for the utilities, facilities, computer systems, and cleanroom environments to meet the requirements for cell-based therapies. The site will be designed to support the production of cell therapies, which necessitates adherence to GMP, regulatory compliance, and the implementation of validation and commissioning processes. They are currently needing a Sr. Validation Engineer to come in and help review the commissioning plan and validating the documentation. They will then begin the commissioning execution for all utilities, facilities and some computer systems. The systems they can expect to be working with are liquid systems, air handling, compressed air, batch record systems and Client and EMS. Develop and Review Validation Protocols. Create and review IQ, OQ, PQ protocols for utilities and facility systems. Ensure protocols meet regulatory requirements. Execute IQ, OQ, and PQ testing on utilities and facility systems Validate the installation, operation, and performance of critical equipment. Conduct FAT and SAT for utilities and equipment. Ensure proper calibration and maintenance schedules are in place for critical utilities and equipment. Validate cleanroom conditions. Conduct smoke studies, airflow tests, and particle count testing for cleanroom and controlled environments. Write technical reports on commissioning, qualification, and validation activities Implement change control procedures for modifications to utilities and facility systems during commissioning. Ensure proper documentation of any system changes, including impact assessments. Collaborate with Engineering and Operations Teams: Work closely with engineering and operations teams to ensure systems are properly commissioned, installed, and tested. Provide guidance to operations teams on system startup and maintenance procedures. Compliance and Regulatory Review: Ensure all validation and commissioning work complies with regulatory guidelines and internal GMP requirement.
Responsibilities
Our client is currently in the process of starting up a clinical cell therapy site with clean rooms. They are in the commissioning phase and validating documentation and processes for the utilities, facilities, computer systems, and cleanroom environments to meet the requirements for cell-based therapies. The site will be designed to support the production of cell therapies, which necessitates adherence to GMP, regulatory compliance, and the implementation of validation and commissioning processes. They are currently needing a Sr. Validation Engineer to come in and help review the commissioning plan and validating the documentation. They will then begin the commissioning execution for all utilities, facilities and some computer systems. The systems they can expect to be working with are liquid systems, air handling, compressed air, batch record systems and Client and EMS. Develop and Review Validation Protocols. Create and review IQ, OQ, PQ protocols for utilities and facility systems. Ensure protocols meet regulatory requirements. Execute IQ, OQ, and PQ testing on utilities and facility systems Validate the installation, operation, and performance of critical equipment. Conduct FAT and SAT for utilities and equipment. Ensure proper calibration and maintenance schedules are in place for critical utilities and equipment. Verify equipment performance against specified requirements. Validate cleanroom conditions. Conduct smoke studies, airflow tests, and particle count testing for cleanroom and controlled environments. Write technical reports on commissioning, qualification, and validation activities Implement change control procedures for modifications to utilities and facility systems during commissioning. Ensure proper documentation of any system changes, including impact assessments. Collaborate with Engineering and Operations Teams: Work closely with engineering and operations teams to ensure systems are properly commissioned, installed, and tested. Provide guidance to operations teams on system startup and maintenance procedures. Compliance and Regulatory Review: Ensure all validation and commissioning work complies with regulatory guidelines and internal GMP requirement.
Requirements
8+ years of experience as a Validation Engineer to include: Experience with full life cycle of validation activities for facilities and utilities systems Experience with validation activities for clean rooms including Cell counters, freezers, air handlers, compressed air, aseptic systems, smoke studies (Air flow visualization studies), Lab systems. Experience validating CSV systems including EVR, SAP, Client 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 Sign in to set job alerts for “Validation Engineer” roles.
Washington, DC $50,000.00-$240,000.00 1 month ago Bethesda, MD $50,000.00-$240,000.00 1 month ago Bethesda, MD $50,000.00-$240,000.00 1 month ago Washington, DC $50,000.00-$240,000.00 1 month ago Washington, DC $80,000.00-$110,000.00 1 week ago Ashburn, VA $104,650.00-$189,175.00 1 day ago McLean, VA $90,000.00-$130,000.00 5 hours ago Annapolis Junction, MD $12,000.00-$180,000.00 1 month ago Herndon, VA $119,000.00-$213,000.00 1 week ago Harmans, MD $118,720.00-$163,240.00 1 day ago Leesburg, VA $105,000.00-$135,000.00 1 week ago Bethesda, MD $10,000.00-$185,000.00 11 hours ago Sr. Supplier Quality Engineer, Intelligence Systems
Herndon, VA $142,000.00-$213,000.00 3 weeks ago Annapolis Junction, MD $134,000.00-$177,000.00 6 days ago Columbia, MD $130,000.00-$180,000.00 1 month ago Columbia, MD $66,000.00-$115,000.00 6 days ago Principal Verification and Validation Engineer
Rockville, MD $115,779.00-$196,825.00 3 days ago Reston, VA $80,000.00-$128,000.00 2 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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CSV Validation Engineer
role at
Katalyst CRO 8 months ago Be among the first 25 applicants Join to apply for the
CSV Validation Engineer
role at
Katalyst CRO Our client is currently in the process of starting up a clinical cell therapy site with clean rooms. They are in the commissioning phase and validating documentation and processes for the utilities, facilities, computer systems, and cleanroom environments to meet the requirements for cell-based therapies. The site will be designed to support the production of cell therapies, which necessitates adherence to GMP, regulatory compliance, and the implementation of validation and commissioning processes. They are currently needing a Sr. Validation Engineer to come in and help review the commissioning plan and validating the documentation. They will then begin the commissioning execution for all utilities, facilities and some computer systems. The systems they can expect to be working with are liquid systems, air handling, compressed air, batch record systems and Client and EMS. Develop and Review Validation Protocols. Create and review IQ, OQ, PQ protocols for utilities and facility systems. Ensure protocols meet regulatory requirements. Execute IQ, OQ, and PQ testing on utilities and facility systems Validate the installation, operation, and performance of critical equipment. Conduct FAT and SAT for utilities and equipment. Ensure proper calibration and maintenance schedules are in place for critical utilities and equipment. Validate cleanroom conditions. Conduct smoke studies, airflow tests, and particle count testing for cleanroom and controlled environments. Write technical reports on commissioning, qualification, and validation activities Implement change control procedures for modifications to utilities and facility systems during commissioning. Ensure proper documentation of any system changes, including impact assessments. Collaborate with Engineering and Operations Teams: Work closely with engineering and operations teams to ensure systems are properly commissioned, installed, and tested. Provide guidance to operations teams on system startup and maintenance procedures. Compliance and Regulatory Review: Ensure all validation and commissioning work complies with regulatory guidelines and internal GMP requirement.
Responsibilities
Our client is currently in the process of starting up a clinical cell therapy site with clean rooms. They are in the commissioning phase and validating documentation and processes for the utilities, facilities, computer systems, and cleanroom environments to meet the requirements for cell-based therapies. The site will be designed to support the production of cell therapies, which necessitates adherence to GMP, regulatory compliance, and the implementation of validation and commissioning processes. They are currently needing a Sr. Validation Engineer to come in and help review the commissioning plan and validating the documentation. They will then begin the commissioning execution for all utilities, facilities and some computer systems. The systems they can expect to be working with are liquid systems, air handling, compressed air, batch record systems and Client and EMS. Develop and Review Validation Protocols. Create and review IQ, OQ, PQ protocols for utilities and facility systems. Ensure protocols meet regulatory requirements. Execute IQ, OQ, and PQ testing on utilities and facility systems Validate the installation, operation, and performance of critical equipment. Conduct FAT and SAT for utilities and equipment. Ensure proper calibration and maintenance schedules are in place for critical utilities and equipment. Verify equipment performance against specified requirements. Validate cleanroom conditions. Conduct smoke studies, airflow tests, and particle count testing for cleanroom and controlled environments. Write technical reports on commissioning, qualification, and validation activities Implement change control procedures for modifications to utilities and facility systems during commissioning. Ensure proper documentation of any system changes, including impact assessments. Collaborate with Engineering and Operations Teams: Work closely with engineering and operations teams to ensure systems are properly commissioned, installed, and tested. Provide guidance to operations teams on system startup and maintenance procedures. Compliance and Regulatory Review: Ensure all validation and commissioning work complies with regulatory guidelines and internal GMP requirement.
Requirements
8+ years of experience as a Validation Engineer to include: Experience with full life cycle of validation activities for facilities and utilities systems Experience with validation activities for clean rooms including Cell counters, freezers, air handlers, compressed air, aseptic systems, smoke studies (Air flow visualization studies), Lab systems. Experience validating CSV systems including EVR, SAP, Client 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 Sign in to set job alerts for “Validation Engineer” roles.
Washington, DC $50,000.00-$240,000.00 1 month ago Bethesda, MD $50,000.00-$240,000.00 1 month ago Bethesda, MD $50,000.00-$240,000.00 1 month ago Washington, DC $50,000.00-$240,000.00 1 month ago Washington, DC $80,000.00-$110,000.00 1 week ago Ashburn, VA $104,650.00-$189,175.00 1 day ago McLean, VA $90,000.00-$130,000.00 5 hours ago Annapolis Junction, MD $12,000.00-$180,000.00 1 month ago Herndon, VA $119,000.00-$213,000.00 1 week ago Harmans, MD $118,720.00-$163,240.00 1 day ago Leesburg, VA $105,000.00-$135,000.00 1 week ago Bethesda, MD $10,000.00-$185,000.00 11 hours ago Sr. Supplier Quality Engineer, Intelligence Systems
Herndon, VA $142,000.00-$213,000.00 3 weeks ago Annapolis Junction, MD $134,000.00-$177,000.00 6 days ago Columbia, MD $130,000.00-$180,000.00 1 month ago Columbia, MD $66,000.00-$115,000.00 6 days ago Principal Verification and Validation Engineer
Rockville, MD $115,779.00-$196,825.00 3 days ago Reston, VA $80,000.00-$128,000.00 2 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr