Validation Engineer I

🕒 Agosto 10

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $20 - $23 / hora

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👷🏻‍♀️ Engenheiro

🦅 Patrocina Visto H1B

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👻 Score fantasma 1%

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🗣️🇺🇸🇬🇧 Inglês obrigatório

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Logo of PSC Biotech Corporation

PSC Biotech Corporation

201 - 500 funcionários

Fundada em 1996

💼 Consultoria

🏥 Saúde

🧬 Biotecnologia

Consulting • Healthcare • Biotechnology

A PSC Biotech Corporation é uma parceira de soluções de consultoria em ciências da vida que oferece uma ampla gama de serviços de engenharia, técnicos e de consultoria focados em melhorar a eficiência operacional, conformidade e garantia de qualidade nos setores de biotecnologia e farmacêutico. Sua expertise inclui áreas como auditoria, assuntos regulatórios, comissionamento, validação e gerenciamento de projetos, ajudando organizações a mitigar riscos e otimizar processos para resultados bem-sucedidos em ambientes regulamentados.

Descrição

• Support system validation and product release processes • Ensure compliance with industry standards and regulatory requirements • Contribute to the development and improvement of validation procedures • Drive overall product excellence • Collaborate with cross-functional teams and external clients on project requirements • Conduct thorough testing for system functionality and reliability using a risk-based validation approach • Support planning, development, and implementation of computer systems validation documentation • Write and execute validation documentation, including requirements specifications, test scripts, summary reports, and trace matrices • Initiate and oversee system CSV change control requests and associated validation documentation • Identify and troubleshoot potential risks and implement required solutions • Participate in team meetings and provide project progress updates • Travel as needed for project assignments and client engagements • Perform additional responsibilities as required

🎯 Requisitos

• Bachelor's degree in related engineering discipline • Entry-level position • Prior internship or project experience in computer systems/software testing and validation • Basic understanding of validation processes and risk-based approach • Familiarity with clinical trial software • Knowledge of the Software Development Cycle preferred • Excellent technical computer skills • Advanced technical writing skills • Familiarity with technical lifecycle documentation in regulated industries • Strong attention to detail and commitment to quality • Excellent communication and interpersonal skills • Excellent time management skills and ability to manage multiple projects effectively • Willingness and ability to travel as needed for project assignments and client engagements • Ability to adapt to different locations, cultures, and work environments • Must be authorized to work in U.S. • No C2C at this time

🏖️ Benefícios

• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents • Insurance options for Employee Assistance Programs, Basic Life Insurance, Long Term Disability and more • 401(k) and 401(k) matching • PTO, Sick Time, and Paid Holidays • Education Assistance • Pet Insurance • Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more) • Financial Perks and Discounts • Compensation and benefits structure that rewards employees • Tools to help employees grow and learn • Coaching and professional development opportunities

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