Manager, Validation

Vertex Pharmaceuticals Incorporated
United States, Massachusetts, Boston
50 Northern Avenue (Show on map)
Mar 01, 2025
Job Description JOB TITLE:Manager, Validation LOCATION: 1 Harbor Street, Boston, MA 02210 OPENINGS:1 DUTIES: Manage the inhouse validation contractors, professional development of personnel and ensure the quality of deliverables within their scope of responsibility. Work with a high degree of independence and troubleshoot problems to create and execute improved internal procedures and to ensure compliance with applicable regulatory requirements. Act as Validation SME to support cGMP systems / programs in accordance with cGMP requirements and Vertex standard practices. Lead validation sub teams with responsibility for defining strategy, planning, coordination, & execution of validation activities. Partner with project managers to determine project priorities, track progress toward project milestones and deliverables, and provide regular project status updates to site management. Provide oversight to project contractors to ensure training, compliance, validation, and schedule requirements are met. Develop validation deliverables as needed such as qualification protocols, gap/risk assessments, user requirements, functional specifications, requirements traceability, plans, reports and change controls. Provide support to audits as needed to assess software development life cycle (SDLC) and equipment engineering methodologies at Suppliers providing manufacturing equipment and control systems. Manage qualification activities and participate in decisions to support implementation of Vertex-owned processing equipment at Vertex sites as well as ensure that appropriate regulations (e.g. 21CFR Part 11 and cGMP) are addressed during validation in a phase appropriate and risk balanced manner. REQUIREMENTS:Employer will accept a Master's degree in Pharmaceutical Science, Engineering, or related field and four (4)years of experience in the job offered or in a Manager, Validation-related occupation Position requires demonstrable experience in the following: Developing validation deliverables including impact assessments, Validation Plans, risk assessments, user requirements specifications, qualification protocols (Installation Qualification, Operational Qualification and Performance Qualification), Gap assessments / Traceability matrices, summary reports or SOPs. Working with the Environmental Monitoring System, Vaisala for temperature mapping to qualify chambers (stability units, freezers, refrigerators) warehouse, transportation truck, freezer and cold rooms. Applying the FMEA process for identifying, assessing, and mitigating risks associated throughout the system lifecycle. Investigating issues, identifying root causes, taking ownership of and implementing corrective and preventive actions (CAPAs) along with effectiveness checks. Utilizing quality management systems and procedures such as Veeva Vault, TrackWise, and Qdoccs, including Corrective and Preventive Actions (CAPA), Change Control, and Document Management. Managing and executing validation projects, including planning, scheduling, resource allocation, and tracking progress to meet timelines and objectives. Operating and maintaining automated manufacturing systems and ability to conduct validation activities following Good Manufacturing Practices (GMP) to demonstrate system reliability, accuracy, and consistency. Using Computerized Maintenance Management Systems such as Maximo or Nuvolo for asset management, work order management, preventive maintenance scheduling, asset tracking, inventory management and reporting capabilities. Providing support in internal and external inspections as a subject matter expert for Validation. Participating in cross-functional strategic discussions as a Validation expert. Evaluating changes to the validated state of systems through change control procedures and contributed in planning and implementation of changes. Developing tools, templates and training materials for validation practices. CONTACT:Send Resume to Sarah Hadjian at sarah_hadjian@vrtx.com. Reference 12140.633. EOE. #LI-DNI 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. 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.