Katalyst Healthcares and Life Sciences
Validation Engineer
Katalyst Healthcares and Life Sciences, Waltham, Massachusetts, United States, 02254
Responsibilities:
Independently perform validation activities including installation qualification, operational qualification, performance qualification for Base Camp projects related to facility, utilities, equipment and instrument. Generate protocols for tests, verification, and qualification for GxP assets, as well as reports to document execution. Ensure deliverables meet the overall facility milestones. Perform and support periodic assessment review and revalidation activities. Ensure deliverables are executed per client Validation Master Plan and other required SOPs. Ensure discrepancies are resolved and closed out in a timely manner. Develop testing templates and qualification protocols using paper and electronic validation systems (Kneat). Perform system impact assessments, risk assessments. Support development and review of engineering lifecycle documents for new and existing equipment. Maintain the Validation Master Plan, engineering lifecycle documents, and validation program SOPs. Support validation activities related to tech transfer projects for all manufacturing suites. Support site capital projects and other improvement projects. Promote engineering best practices, Elevate SOPs, and cGMP regulations. Work with Quality Assurance to ensure all validation activities are in compliance. Support and execute Change Controls to qualified facilities, equipment, and utilities. Requirements:
2-4 years of experience in biotech engineering or an FDA regulated manufacturing facility. BS degree in engineering field or equivalent experience. Experience in cGMP facility/equipment start-up, commissioning, and qualification. Experience in cGMP processes such upstream cell expansion, downstream purification, and fill finish. Viral vector & Cell/Gene Therapies experience is a plus. Experience in using Kneat is a plus. Strong understanding of ASTM E2500 standards for commissioning, validation, and lifecycle management of GMP equipment and systems and GxP laboratories. Required experience with good documentation practices and cGMP standards. bility to work on multiple tasks simultaneously. bility to manage priorities, deliverables, and schedule milestones. Strong interpersonal, verbal communication, and technical writing skills.
Independently perform validation activities including installation qualification, operational qualification, performance qualification for Base Camp projects related to facility, utilities, equipment and instrument. Generate protocols for tests, verification, and qualification for GxP assets, as well as reports to document execution. Ensure deliverables meet the overall facility milestones. Perform and support periodic assessment review and revalidation activities. Ensure deliverables are executed per client Validation Master Plan and other required SOPs. Ensure discrepancies are resolved and closed out in a timely manner. Develop testing templates and qualification protocols using paper and electronic validation systems (Kneat). Perform system impact assessments, risk assessments. Support development and review of engineering lifecycle documents for new and existing equipment. Maintain the Validation Master Plan, engineering lifecycle documents, and validation program SOPs. Support validation activities related to tech transfer projects for all manufacturing suites. Support site capital projects and other improvement projects. Promote engineering best practices, Elevate SOPs, and cGMP regulations. Work with Quality Assurance to ensure all validation activities are in compliance. Support and execute Change Controls to qualified facilities, equipment, and utilities. Requirements:
2-4 years of experience in biotech engineering or an FDA regulated manufacturing facility. BS degree in engineering field or equivalent experience. Experience in cGMP facility/equipment start-up, commissioning, and qualification. Experience in cGMP processes such upstream cell expansion, downstream purification, and fill finish. Viral vector & Cell/Gene Therapies experience is a plus. Experience in using Kneat is a plus. Strong understanding of ASTM E2500 standards for commissioning, validation, and lifecycle management of GMP equipment and systems and GxP laboratories. Required experience with good documentation practices and cGMP standards. bility to work on multiple tasks simultaneously. bility to manage priorities, deliverables, and schedule milestones. Strong interpersonal, verbal communication, and technical writing skills.