Validation Engineering Senior Specialist

Job Description

The Validation Engineering Senior Specialist provides science-centric facility, equipment, instruments, and utility Validation expertise with primary focus for the new cell and gene therapy facility in South Boston.

This role will involve in various aspects of validation efforts for existing and new capital projects, enhancements and capabilities from conceptual to detailed design, installation, startup, testing, commissioning, qualification, and Validation.

• Collaborate with the scientific groups to learn and understand the evolving science and technology at all global sites
• Implement science centric strategic decisions for capital projects and Validation based on the scientific knowledge, education and experience
• Participate in design reviews for various capital projects and equipment with cost, efficiency and compliance always in mind
• Manage in-house and seasonal consultants supporting key CQV deliverables.
• Perform validation assessments for new capital equipment/projects at the new cell and gene therapy facility.
• Provide SME support for regulatory inspections from facility design and Validation standpoint.
• Influence peers to consistently implement continuous improvements to existing and new facilities/equipment.
• Collaborate to ensure all Engineering and Validation KPIs, are appropriately monitored, tracked, and reported.
• Lead and participate (as needed) in troubleshooting of process equipment, facility equipment and associated utilities to resolve any observed discrepancies.
• Work collaboratively with Manufacturing, Process/Analytical Development, R&D groups, EH&S, Capital Project Management, GIS, QA and others to support the consistent achievement of the company's strategic objectives
• Cultivate change and innovation by seeking opportunities to strengthen and improve existing engineering services

• Bachelor's degree in Mechanical, Electrical, Civil, Industrial or Chemical Engineering, or a related discipline
• 4+ years of relevant experience
• Master's degree in Engineering or related discipline preferred but not required

SKILLS/ABILITIES:

• Candidate must be responsive to change and adapt quickly to changing circumstances
• Must demonstrate effective self-management and act on improvement opportunities
• Developed verbal and written communication skills and interpersonal skills to explain complex
• information to others in straightforward situations
• Ability to navigate and be successful in a fast-paced, highly matrixed work environment
• Knowledge of current applicable regulatory expectations
• Expertise supporting manufacturing equipment, analytical instruments, facilities, and utilities Validation.
• Experience with the detailed design process as well as oversight of installation, startup, testing, and thorough commissioning of equipment/systems

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at (see application details).