GxP Facilities Lead- Manager

Job Description TITLE: GxP Facilities Lead - Manager DEPARTMENT: Leiden Center 1: GxP Facility Operations and Engineering POSITION SUMMARY: The GxP Facilities Lead- Manager is responsible for providing support to the Vertex''s GxP Facilities Operations and Engineering teams at Vertex GxP Facilities. The role reports to the Senior Manager, GxP Facility Operations/Engineering, or designee. The Facilities Lead will drive continuous improvement initiatives, maintain best practices, and manages daily facility support of planned and unplanned maintenance to maintain an audit-ready state of the GMP Cell Therapy Manufacturing Operations at LC1 as it relates to the facility and equipment/systems. In addition, this position will be responsible for facility support of GMP deviation investigations, manage contractor activity, and support clean utility compliance in an SME role. KEY RESPONSIBILITIES: Responsible for completing and/or reviewing work requests, maintenance projects, and operational assignments with minimal supervision, escalating when appropriate and necessary. Escort vendors and ensure compliance with standard operations procedures (SOP) Be proficient in the operation of the automation systems (Pi, EMS and BMS and standalone PLC''s), and understand the sequences required for proper building/equipment/system operation. Responsible for system monitoring and alarm responses per SOP''s. Effectively work with cross departmental stakeholders to achieve departmental goals and objectives Apply GEP (Good Engineering Practice) to troubleshoot facility, equipment or system issues On call responsibilities will be required on a rotating basis to cover for any off-hour emergencies Maintain proper housekeeping practices to ensure a safe and clean working environment. Comply with OSHA safety policies, regulations, and company/site procedures Ensure 100% compliance with assigned training curriculum Provide leadership on routine and non-routine maintenance activities Participate in Event Investigations, root-cause analysis and make CAPA recommendations as required Oversee monitoring of critical utilities, including but not limited to WFI and RO systems in addition to PH and bio-kill systems Assist in execution of site PMs, corrective actions and calibrations Adhere to GMP and ROW regulatory requirements Build and sustain strong relationships with internal and external stakeholders including but not limited to Manufacturing and Quality Assurance teams Working knowledge of power and hand tools Ability to read system and engineering drawings (P&IDs) KNOWLEDGE & SKILLS: Demonstrate strong planning and organizational skills. Ability to lead by influence. Foster positive change and drive innovation - seek solutions that strengthen quality, value, service and effectiveness Demonstrates functional/technical proficiency Accountable for results - translates goals/objectives into actionable plans and results Able to work on multiple projects and manage various priorities and timelines Demonstrates proficiency in the following competencies:Responsive to change - adapts (quickly) to changing circumstances Strong collaboration and commitment - focus on team success before individual success Demonstrates operational excellence - continually look for new and better ways to achieve gains in KPI''s and other critical business metrics Demonstrates effective self-management - seek to understand and act upon improvement opportunities Strong interpersonal skills including the demonstrated ability to manage through influence. Ability to navigate and be successful in a fast-paced, highly matrixed work environment Excellent verbal and written communication skills BASIC QUALIFICATIONS: Bachelor''s Degree in Engineering or Facility Management, advance degree a plus. 3-5 years'' work experience in a technical field, GMP preferable Hands-on experience with electrical, HVAC, mechanical, plumbing, and mechanical equipment maintenance, and operations in a GMP environment. Experience with operating Pi, EMS, JCI Metesys BMS and Nuvolo CMMS preferred Physical abilities include but not limited to, lifting objects up to 50lbs, able to be on feet all day, climb steps and ladders as required by job. LI-TH1 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 [Click Here to Email Your Resumé]. This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.

Created: 2025-11-15