COMPUTER SYSTEM VALIDATION ENGINEER - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
Responsibilities:
· Lead the generation of key deliverables in a phase appropriate compliance manner as part of global CQV strategy for F&U, Equipment, QC/Analytical, Cleaning and Shipping
· Support development of robust collaboration for CSV and Process Validations
· Support the development of the qualification and validation programs at Just including the transition from paper based to digital validation software to configure globally scalable end to end paperless solutions to manage the validation lifecycle
· Develop and strategize compliant and Client ways to comply with regulatory requirements
· Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings
· Lead CQV activities across global expansion sites
Education and Qualification Requirements:
· Bachelor's degree in engineering science or related program with at least 7+ years in relevant experience
· Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems, equipment, utilities, and/or facilities
· Working knowledge of US FDA CFRs and European EMA, including ICH regulations
· Experience authoring, reviewing, and approving validation documentation
· High level oral and written communication skills are a must
Additional Qualifications:
· Understanding of process automation (e.g. DeltaV) with previous experience with Distributed Control System (DCS), Building Automation Systems (Client), PLC, SCADA, PI, and MES will be a plus
· Applies knowledge and expertise to solve complex technical problems
· Significant contributor to multi-disciplinary teams at the functional level
· Led a team or large validation projects
· Direct working knowledge of utilities, facilities, computerized system, and analytical equipment
· Working knowledge of shipping, transport logistics, cleaning validation methodologies and process validation
· Lead the generation of key deliverables in a phase appropriate compliance manner as part of global CQV strategy for F&U, Equipment, QC/Analytical, Cleaning and Shipping
· Support development of robust collaboration for CSV and Process Validations
· Support the development of the qualification and validation programs at Just including the transition from paper based to digital validation software to configure globally scalable end to end paperless solutions to manage the validation lifecycle
· Develop and strategize compliant and Client ways to comply with regulatory requirements
· Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings
· Lead CQV activities across global expansion sites
Education and Qualification Requirements:
· Bachelor's degree in engineering science or related program with at least 7+ years in relevant experience
· Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems, equipment, utilities, and/or facilities
· Working knowledge of US FDA CFRs and European EMA, including ICH regulations
· Experience authoring, reviewing, and approving validation documentation
· High level oral and written communication skills are a must
Additional Qualifications:
· Understanding of process automation (e.g. DeltaV) with previous experience with Distributed Control System (DCS), Building Automation Systems (Client), PLC, SCADA, PI, and MES will be a plus
· Applies knowledge and expertise to solve complex technical problems
· Significant contributor to multi-disciplinary teams at the functional level
· Led a team or large validation projects
· Direct working knowledge of utilities, facilities, computerized system, and analytical equipment
· Working knowledge of shipping, transport logistics, cleaning validation methodologies and process validation
Source : Katalyst Healthcares & Life Sciences
