Validation Engineer I at PSC Biotech® Corporation in Remote

Summary: PSC Biotech® Corporation is a leading provider of essential services in the life sciences sector, ensuring compliance with regulatory requirements. They are seeking a Validation Engineer I to support system validation and product release processes while contributing to the development and improvement of validation procedures.

Responsibilities:
- Collaborate with cross-functional teams and external clients to ensure alignment on project requirements
- Conduct thorough testing to ensure system functionality and reliability, utilizing a risk-based validation approach
- Support the planning, development, and implementation of computer systems validation documentation
- Write and execute required validation documentation including requirements specifications, test scripts, summary reports, trace matrices, etc
- Initiate and oversee system CSV associated change control requests and associated validation documentation
- Identify and troubleshoot any potential risks and effectively implement required solutions
- Ensure compliance with industry standards and regulatory requirements
- Participate in team meetings and provide updates on projects progress
- Additional responsibilities as required

Required Qualifications:
- Bachelor's degree in related engineering discipline
- This is an entry-level position. Prior internship or project experience within computer systems/software testing and validation
- Basic understanding of validation processes and risk-based approach
- Familiar with clinical trial software
- Excellent technical computer skills
- Advanced technical writing skills, and familiar with technical lifecycle documentation in regulated industries
- Strong attention to detail with a commitment to quality
- Excellent communication and interpersonal skills
- Excellent time management skills with the ability to manage multiple projects effectively
- Must be authorized to work in U.S
- No C2C at this time

Preferred Qualifications:
- Knowledge of the Software Development Cycle

Required Skills: System validation, Product release processes, Risk-based validation approach, Computer systems validation documentation, Validation documentation writing, Requirements specifications, Test scripts, Trace matrices, Change control requests, Clinical trial software, Software Development Cycle, Technical computer skills

Benefits: 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