Senior Validation Analyst

Theradex Systems, Inc.

Theradex is an Equal Opportunity Employer.

US-NJ-Princeton | US

Celebrating 40+ years! Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.

As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, and as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.

Location:

Remote Preference given to applicants residing in the Tri-State Region.

This is an ideal opportunity for someone who thrives in a fast-paced, dynamic environment where adaptability, critical thinking, and initiative are essential.

As the Senior Validation Analyst you will:

• Design and develop comprehensive validation plans and testing strategies, utilizing a risk-based approach to identify and prioritize critical areas.
• Ensure all validation activities adhere to relevant regulations and standards, including GxP, GAMP, and 21 CFR Part 11.
• Validate and test applications built on cloud storage or relational databases (e.g., Oracle, MS SQL), focusing on data flow integrity, accuracy, and traceability. This includes reviewing test data, interpreting data mapping, and analyzing results.
• Manage the creation and maintenance of validation documentation throughout the Software Development Life Cycle (SDLC). This includes developing validation packages with plans, traceability matrices, test scripts (Functional, UAT, Performance, Integration, Regression), and summary reports.
• Conduct risk and impact assessments for system changes to determine the necessary validation deliverables and rapidly identify critical validation areas.
• Perform defect analysis to provide actionable insights for developers, differentiate between system issues and evolving user requirements, and identify ways to streamline validation processes.
• Serve as a subject matter expert on cross-functional teams, providing feedback on requirements to ensure they are clearly defined and testable.
• Mentor junior testers on formal test execution and documentation, while also communicating roadblocks and challenges to ensure timely project completion.

• Bachelor's degree required.
• 8+ years prior experience inclusive of computer systems validation required.
• Strong experience working with relational databases (Oracle, MS SQL).
• Prior experience in a CRO/pharmaceutical environment, preferred.

• Technical and Regulatory Expertise:
  Strong understanding of regulatory guidelines for computer systems, including validation methodologies like SDLC and Agile and knowledge of web technology, cloud-based systems, and SQL.
• Analytical and Problem-Solving
  
  Skills:
  
  Proven ability to research and analyze system requirements, develop alternatives, and implement solutions. Excels in analytical, problem-solving, and technical tasks with a keen attention to detail.
• Communication and Documentation:
  Demonstrates strong communication skills, both verbal and written, with a focus on clear and effective documentation.
• Professional and Interpersonal
  
  Skills:
  
  A highly organized, result-oriented self-starter who can work both independently and collaboratively in cross-functional teams. Comfortable in fast-paced environments with evolving priorities and possesses excellent interpersonal skills.
• Computer Proficiency:
  Proficient in essential computer applications, including Microsoft Word, PowerPoint, and advanced knowledge of Excel.

• Able to work effectively as an onsite or remote worker.
• Must be highly fluent in English.
• Willing to travel to meetings in Princeton, NJ as needed. Advance notice will be provided.

At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $90,000-$130,000 with bonus potential.

The actual salary offer will be based on a number of factors, including but not limited to the candidate's qualifications, experience, skills, and competencies for the role.

This position is not eligible for…