Job description
Job Description
The Facilities Engineering Senior Specialist is a site lead role to provide science-centric facility, equipment, instruments, and utility engineering expertise with primary focus for the Vertex Manufacturing Center, small molecule facility in South Boston.
The role will involve engineering conceptual to detailed design, project management, commissioning and change control management for facility related projects including manufacturing equipment, clean room, laboratory, and manufacturing suite renovations.
Key Duties and Responsibilities:
- Collaborate with the scientific groups to learn and understand the evolving science and technology at all global sites
- Lead a team that executes change management for manufacturing equipment and other support systems including commissioning and/or implementation of other related initiatives as assigned
- Own and perform Biennial review for engineering owned SOPs
- 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.
- Manage creation and revision of commissioning protocols, reports, and engineering documents including, but not limited to, CQV, drawings, user requirement specifications and SOP’s.
- Perform engineering assessments for new capital equipment/projects.
- Provide SME support for regulatory inspections from facility design and engineering standpoint.
- Influence peers to consistently implement continuous improvements to existing and new facilities/equipment.
- Collaborate to ensure all Engineering 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
Knowledge and Skills:
- 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 is required
- Experience of cGMP and regulated facility design, change control processes, compliance requirements, commissioning, qualification, validation, and best practices in the pharmaceutical industry
- Must exhibit mechanical abilities including tool familiarity, lifting, climbing a ladder and ability to gown into cleanrooms
Basic Requirements:
- Bachelor's degree in Mechanical, Electrical, Civil, Industrial or Chemical Engineering, or a related discipline
- Master's degree in Engineering or related discipline preferred but not required
- Typically requires 5 years of relevant work experience with experience in planning, design and execution of R&D/Office facility-focused engineering projects; OR, any equivalent combination of experience and/or education from which comparable knowledge, skills, and abilities have been achieved
- #LI-SR1 #LI-ONSITE
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 ApplicationAssistance@vrtx.com.
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