Katalyst Healthcares and Life Sciences
Warehouse CQV Engineer
Katalyst Healthcares and Life Sciences, Newark, Delaware, United States, 19711
Responsibilities:
Provide technical CQV (commissioning, qualification, and verification) expertise on large capital projects involving new or modified equipment, facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently. Author and execute documents such as URS, System Boundary Definition, Risk Assessment, Traceability Matrices, Design Qualification, Start Up and Debug documentation, commissioning documents, including FAT and SAT, IQ/OQ/PQ, and Turnover documentation. Support technical commissioning and qualification documentation for complex, automated equipment, and processes, in accordance with client's quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards. Verify system drawings including ability to review and as-build P&IDs and I&C drawings as well as verifying electrical schematics with electrical engineering support. Manage and work collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits. roject assignments will vary by customer requirements for specific defined deliverables based on project needs and scope. #LI-MC1 Requirements
Bachelor's degree in an Engineering or Scientific field, or equivalent 1-3 years' experience in GMP regulated environment. Experience supporting, writing and executing GMP documentation and validation protocols. Experience working in a GMP-regulated warehouse facility. Experience commissioning warehouse equipment, such as pallet transfer systems. Proven ability to work effectively with a team and in a client-facing environment; excellent verbal and written communication skills.
Provide technical CQV (commissioning, qualification, and verification) expertise on large capital projects involving new or modified equipment, facilities, and utilities ensuring CQV aspects are delivered consistently and efficiently. Author and execute documents such as URS, System Boundary Definition, Risk Assessment, Traceability Matrices, Design Qualification, Start Up and Debug documentation, commissioning documents, including FAT and SAT, IQ/OQ/PQ, and Turnover documentation. Support technical commissioning and qualification documentation for complex, automated equipment, and processes, in accordance with client's quality standards, current Good Manufacturing Practices, (21 Code of Federal Regulations Part 210, 211 and 820 level standards which apply to the equipment and product being validated) and national/international standards. Verify system drawings including ability to review and as-build P&IDs and I&C drawings as well as verifying electrical schematics with electrical engineering support. Manage and work collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Maintain clear and detailed records of qualification and change control activities for future compliance audits. roject assignments will vary by customer requirements for specific defined deliverables based on project needs and scope. #LI-MC1 Requirements
Bachelor's degree in an Engineering or Scientific field, or equivalent 1-3 years' experience in GMP regulated environment. Experience supporting, writing and executing GMP documentation and validation protocols. Experience working in a GMP-regulated warehouse facility. Experience commissioning warehouse equipment, such as pallet transfer systems. Proven ability to work effectively with a team and in a client-facing environment; excellent verbal and written communication skills.