Job Description

Summary of Responsibilities:

• Demonstrate the ability to multi-task and manage validation activities for a project effectively.
• Lead the development and implementation of solutions to global technical services issues and concerns regarding Validation activities.
• Plan and establish timelines to meet or exceed client expectations for validations.
• Act as Subject Matter Expert (SME) and be point of contact for any technical services, issues related to Validation process.
• Review clinical project specification documentation to create appropriate testing methodologies.
• Create and Execute validation test scripts as requested and document the test results.
• Write and review validation documentation to support projects.
• Able to work independently and take initiative to accept new challenges in the validation tasks and new or updates to software.
• Resource forecasting and allocate activities to the team members on the project.
• Work with other team members to create appropriate testing environments to support testing methodologies.
• Exhibit good imparting, analytical skills along with testing, troubleshooting, error fixing, and documentation skills.
• Conduct Peer Review/Quality control of study design for assigned projects.
• Utilize strong working knowledge of SOPs, validation standards, and work procedures to suggest potential improvements and to provide training and guidance to all critical staff.
• Assist in the support of regulatory and client audits of validation activities and documents.
• Support management of metrics.
• Assist with investigating or resolving issues of patient safety or quality as directed.
• Proactively identify trends, generate reports/metrics, or demonstrate Validation process to sponsors/auditors (if required), assist with the validation and other study documents.
• Understand implications of activities on project budgets.
• Suggest process improvements at various levels of validation process.
• Assist in developing key metrics for process improvement.
• Train, Mentor and support the team in their understanding and adoption of validation concepts and responsibilities.
• Active member of SOP review team as assigned.
• Lead or assist with special projects as designated.
• All other duties as needed or assigned.

Qualifications (Minimum Required):

• University / college degree (life sciences, health sciences, information technology or related subjects preferred).
• Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.

Experience (Minimum Required):

• 4 - 6 years of relevant work experience to include Validation support and execution.
• Good problem-solving skills and a proactive approach.
• Strong communication and interpersonal skills.
• Strong attention to detail.
• Problem solving/logic skills.
• Good time management skills and maintain the highest standards of quality work.
• A neat, methodical, and thorough approach to the work with an emphasis on attention to detail.
• Good concentration skills are required to meet the consistently high standards expected.
• Self-motivation with the ability to work under pressure to meet demanding deadlines.
• Strong analytical skills and attention to detail, preferably in a GCP environment.
• Ability to prioritize work.
• Effective communication skills and the ability to work as part of a team.
• Flexibility - being able to move from one computer system to another with ease and adapt to new technology and a constantly changing work environment.

Preferred Qualifications Include:

• University / college degree (life sciences, health sciences, information technology or related subjects preferred).

Physical Demands/Work Environment:

• Office work environment.

Learn more about our EEO & Accommodations request here.