Validation Engineer I

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $20 - $23 / hour

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷🏻‍♀️ Engineer

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PSC Biotech Corporation

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1996

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

PSC Biotech Corporation is a life science consulting solutions partner that offers a wide range of engineering, technical, and consulting services focused on enhancing operational efficiency, compliance, and quality assurance within the biotech and pharmaceutical sectors. Their expertise includes areas such as auditing, regulatory affairs, commissioning, validation, and project management, helping organizations mitigate risks and streamline processes for successful outcomes in regulated environments.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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