Katalyst Healthcares and Life Sciences
Equipment Validation
Katalyst Healthcares and Life Sciences, Rensselaer, New York, United States, 12144
Responsibilities:
The role focuses on the execution of qualifying and commissioning new equipment from scratch within a facility, with a primary emphasis on fill-finish operations. The position requires a strong technical background in equipment qualification, IQ/OQ, and aseptic processing, as well as experience with paper-based documentation systems.Lead the qualification and commissioning of new equipment within a fill-finish environment.Execute IQ/OQ protocols and ensure equipment meets GMP requirements.Review and generate documentation protocols, including IQ/OQ binders, summary reports, and turnover packages from vendors.Perform documentation reviews and generate necessary paperwork in compliance with GDP standards.Manage paper-based documentation systems and ensure accuracy and completeness in all records.Ensure compliance with GMP executions and aseptic processing procedures.Collaborate with cross-functional teams, including automation and validation, to ensure successful equipment commissioning.Requirements:
4-5 years of experience in equipment qualification and commissioning.Strong knowledge and hands-on experience with IQ/OQ processes.Experience in fill-finish environments and aseptic processing.Familiarity with GDP and GMP executions in pharmaceutical or life sciences settings.Experience working with paper-based documentation systems.bility to review, perform, and generate detailed documentation for equipment qualification.Coachable, adaptable, and able to work well in a team-oriented environment.Strong technical knowledge related to equipment qualification and commissioning.Experience in GMP environments.Familiarity with turnover packages from vendors.bility to perform floor execution during equipment commissioning.
The role focuses on the execution of qualifying and commissioning new equipment from scratch within a facility, with a primary emphasis on fill-finish operations. The position requires a strong technical background in equipment qualification, IQ/OQ, and aseptic processing, as well as experience with paper-based documentation systems.Lead the qualification and commissioning of new equipment within a fill-finish environment.Execute IQ/OQ protocols and ensure equipment meets GMP requirements.Review and generate documentation protocols, including IQ/OQ binders, summary reports, and turnover packages from vendors.Perform documentation reviews and generate necessary paperwork in compliance with GDP standards.Manage paper-based documentation systems and ensure accuracy and completeness in all records.Ensure compliance with GMP executions and aseptic processing procedures.Collaborate with cross-functional teams, including automation and validation, to ensure successful equipment commissioning.Requirements:
4-5 years of experience in equipment qualification and commissioning.Strong knowledge and hands-on experience with IQ/OQ processes.Experience in fill-finish environments and aseptic processing.Familiarity with GDP and GMP executions in pharmaceutical or life sciences settings.Experience working with paper-based documentation systems.bility to review, perform, and generate detailed documentation for equipment qualification.Coachable, adaptable, and able to work well in a team-oriented environment.Strong technical knowledge related to equipment qualification and commissioning.Experience in GMP environments.Familiarity with turnover packages from vendors.bility to perform floor execution during equipment commissioning.