Validation Engineer I

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in the validation of systems and the processes involved in product releases.

• Ensure adherence to industry standards and regulatory obligations.

• Contribute to the enhancement and development of validation procedures.

• Promote overall excellence of products.

• Collaborate with cross-functional teams and external clients to define project requirements.

• Perform comprehensive testing to assess system functionality and reliability utilizing a risk-based validation methodology.

• Aid in the planning, development, and execution of computer systems validation documentation.

• Draft and carry out validation documentation, which includes requirements specifications, test scripts, summary reports, and trace matrices.

• Initiate and manage change control requests for system CSV and the corresponding validation documentation.

• Recognize and address potential risks, implementing necessary solutions.

• Engage in team meetings and deliver updates on project progress.

• Travel as necessary for project assignments and client interactions.

• Undertake additional responsibilities as required.

⛳️ Requirements

• A Bachelor's degree in a relevant engineering field.

• This is an entry-level position.

• Previous internship or project experience in computer systems/software testing and validation.

• Basic knowledge of validation processes and a risk-based approach.

• Familiarity with clinical trial software.

• Understanding of the Software Development Cycle is preferred.

• Strong technical computer skills.

• Proficient technical writing abilities.

• Familiarity with technical lifecycle documentation in regulated sectors.

• Keen attention to detail and a strong commitment to quality.

• Excellent communication and interpersonal skills.

• Effective time management skills with the ability to handle multiple projects simultaneously.

• Willingness and capability to travel as required for project assignments and client interactions.

• Ability to adapt to various locations, cultures, and work environments.

• Must have authorization to work in the U.S.

• Currently, no C2C opportunities available.

🏝️ Benefits

• Medical, Dental, and Vision - PSC covers 100% of qualifying employee medical premiums and 50% for eligible dependents.

• Options for insurance covering Employee Assistance Programs, Basic Life Insurance, Long-Term Disability, and more.

• 401(k) plan with matching contributions.

• Paid Time Off (PTO), Sick Leave, and Paid Holidays.

• Education Assistance programs.

• Pet Insurance coverage.

• Fitness Benefits, including membership discounts and additional perks/services at eligible gyms such as Anytime Fitness, 24-Hour Fitness, and more.

• Financial perks and discounts available.

• A compensation and benefits structure designed to reward employees.

• Resources to support employee growth and learning.

• Opportunities for coaching and professional development.