Remote Validation Engineer I: Life Sciences

PSC Biotech; Northern (KY); Hybrid; USD 42,000 - 48,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401(k) plan

PTO/Sick Time/Holidays

Education Assistance

Pet Insurance

Fitness benefits

Job summary

PSC Biotech is hiring an Entry-Level Validation Engineer I to support system validation and product release processes, ensuring regulatory compliance. The role emphasizes development of validation procedures, execution of test scripts, and change control documentation within a fully remote setup.

Ideal candidates hold a bachelor’s degree in an engineering discipline, with exposure to system/software testing in the life sciences.

Qualifications

• Entry-level position requiring a bachelor's degree in an engineering discipline.
• Prior internship or project experience in computer systems/software testing and validation is preferred.
• Basic understanding of validation processes and risk-based approaches.
• Familiarity with clinical trial software.
• Knowledge of the Software Development Life Cycle is preferred.
• Advanced technical writing skills and experience with lifecycle documentation in regulated industries.

Responsibilities

• Collaborate with cross-functional teams and external clients to align on project requirements.
• Conduct thorough testing to ensure system functionality and reliability using a risk-based validation approach.
• Support planning, development, and implementation of computer systems validation documentation.
• Write and execute validation documents including requirements specs, test scripts, and trace matrices.
• Initiate and manage CSV-related change control requests and related validation documentation.
• Identify and troubleshoot risks and implement solutions to maintain compliance with standards.
• Participate in team meetings and provide project progress updates.

Skills

Communication skills

Time management

Attention to detail

Technical writing

Interpersonal skills

Travel willingness

Education

Bachelor's degree in engineering

Tools

Clinical trial software

Software Development Life Cycle

Job description

PSC Biotech is hiring an Entry-Level Validation Engineer I to support system validation and product release processes, ensuring regulatory compliance. The role emphasizes development of validation procedures, execution of test scripts, and change control documentation within a fully remote setup.

Ideal candidates hold a bachelor’s degree in an engineering discipline, with exposure to system/software testing in the life sciences.