Sr. Validation Engineer - Clinical Computation Platform

Roles & Responsibilities:

• Develop detailed test plans and strategies based on project requirements and specifications
• Perform manual and automated testing of software applications, including functional, regression, and performance testing
• Document and report defects and issues identified during testing, and work with development teams to resolve them
• Maintain detailed documentation of test/validation plans, test cases, and test results
• Validate that test scenarios meet feature acceptance criteria and customer expectations
• Maintain and ensure the quality of documented user stories/requirements in tools such as Jira
• Provide experienced technical support in validation to meet objectives of quality, output and cost in developing, trouble shooting, standardizing and improving new and existing equipment
• Prepare, execute, document, and report validation protocols in line with GxPs and other regulatory requirements and standards
• Assure that all validation test procedures are in line with current technology, corporate, and governmental regulations
• Perform IQ, OQ, and PQ validation on processes, equipment, and systems in conjunction with suppliers as appropriate

Basic Qualifications:

• Masters degree with 4 - 6 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR
• Bachelors degree with 6 - 8 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience OR
• Diploma with 10 - 12 years of experience in Life Science/Biotechnology/Pharmacology/Information Systems experience

Functional Skills:

Must-Have Skills:

• Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology
• Experience with Agile software development methodologies (Scrum)
• Excellent communication skills and the ability to interface with senior leadership with confidence and clarity
• Experience with validation solutions, including compliance and data integrity.

Good-to-Have Skills:

• Familiarity with cloud validation (AWS / Azure / GCP).
• Experience with validation solutions, including compliance and data integrity.
• Able to communicate technical or complex subject matters in business terms
• Jira Align experience

Professional Certifications

• SAFe for Teams certification (preferred)

Soft Skills:

• Able to work under minimal supervision
• Excellent analytical and troubleshooting skills
• Strong verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully
• Team-oriented, with a focus on achieving team goals
• Strong presentation and public speaking skills