qatechnical writinggmpfreelancequalificationlife scienceschange controlcomputer system validationvalidation protocols
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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Текст:
Hirify AI/Оригинал
TL;DR
Validation Engineer (Life Sciences): Supporting computerized system qualification and validation in a regulated life sciences environment with an accent on validation documentation, GMP compliance, and system lifecycle activities. Focus on developing and executing validation protocols, resolving discrepancies, and maintaining audit-ready records across Quality, Engineering, IT, and system-owner stakeholders.
Location: Columbia, Missouri, United States; travel may be required for project assignments and client engagements.
Contract: 6-month W2 temporary contract with potential for extension.
Company
hirify.global provides life sciences services supporting the development, manufacturing, and distribution of healthcare products in compliance with regulatory requirements.
What you will do
Support the qualification and validation of computerized systems throughout their lifecycle.
Develop, review, and execute computer system validation and qualification documentation and protocols.
Review system requirements for completeness and compliance with established procedures.
Identify, document, and support resolution of discrepancies and deviations.
Collaborate with Quality, Engineering, IT, and system owners on validation activities.
Support change control, inspection readiness, and audit-ready validation records in alignment with GMP and site procedures.
Requirements
Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical discipline, or equivalent relevant experience.
Previous experience with computerized system validation (CSV) and/or computerized system qualification in a regulated environment.
Working knowledge of validation lifecycle principles, documentation, GMP-regulated systems, and applicable quality requirements.
Experience developing, reviewing, and/or executing validation or qualification documentation.
Ability to identify and document discrepancies and support resolution of validation issues.
Strong technical writing, documentation, organizational, communication, and collaboration skills.
Ability to manage multiple validation activities and priorities with close attention to detail.
Must be legally authorized to work in the United States.
C2C arrangements are not considered.
Ability and willingness to travel as needed for project assignments and client engagements and adapt to different locations, cultures, and work environments.
Culture & Benefits
6-month W2 temporary employment with potential for extension.
Medical and sick time benefits are included for W2 temporary roles.
Work in a multicultural environment with opportunities for coaching, professional development, and learning.
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