Katalyst CRO
Overview
Join to apply for the
Software Validation Engineer
role at
Katalyst CRO . Location: Plymouth, MN. Responsibilities
Responsible for SW Validation planning, requirement gathering, risk assessment, protocol development and test execution. Work with cross functional team and SME to understand the intended use and prepare the above documentation. Qualifications
Bachelor's degree in computer science, Information Technology, Electronics Engineering, or a related field. Minimum 5-8 years of experience in software validation, preferably within the medical device, pharmaceutical, or regulated healthcare industries. Strong understanding of software development lifecycle (SDLC) methodologies, validation planning, risk management, and quality assurance principles. Experience in handling SW development and verification tools. Good exposure to FDA regulations (21 CFR Part 11, Part 820), ISO 13485, EU MDR, GAMP 5, and other relevant standards for software lifecycle and validation. Experience with computerized system validation (CSV) approaches for non-product applications. Proficiency in authoring validation documents as per SOP or work instruction. Seniority level: Mid-Senior level. Employment type: Contract. Job function: Information Technology. Industries: Pharmaceutical Manufacturing. Notes
Referrals increase your chances of interviewing at Katalyst CRO. Get notified about new Software Validation Engineer jobs in Plymouth, MN.
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Join to apply for the
Software Validation Engineer
role at
Katalyst CRO . Location: Plymouth, MN. Responsibilities
Responsible for SW Validation planning, requirement gathering, risk assessment, protocol development and test execution. Work with cross functional team and SME to understand the intended use and prepare the above documentation. Qualifications
Bachelor's degree in computer science, Information Technology, Electronics Engineering, or a related field. Minimum 5-8 years of experience in software validation, preferably within the medical device, pharmaceutical, or regulated healthcare industries. Strong understanding of software development lifecycle (SDLC) methodologies, validation planning, risk management, and quality assurance principles. Experience in handling SW development and verification tools. Good exposure to FDA regulations (21 CFR Part 11, Part 820), ISO 13485, EU MDR, GAMP 5, and other relevant standards for software lifecycle and validation. Experience with computerized system validation (CSV) approaches for non-product applications. Proficiency in authoring validation documents as per SOP or work instruction. Seniority level: Mid-Senior level. Employment type: Contract. Job function: Information Technology. Industries: Pharmaceutical Manufacturing. Notes
Referrals increase your chances of interviewing at Katalyst CRO. Get notified about new Software Validation Engineer jobs in Plymouth, MN.
#J-18808-Ljbffr