QE Execution Staff, Manufacturing Technical Operations (contract) 822
Vertex Pharmaceuticals
Summary
This staff member on the MTO is responsible for ownership and execution of quality records including Deviations, CAPAs, Change Controls, and Analytical and Quality Control Investigations supporting cell manufacturing at our Boston site. This includes all aspects of QE execution including data review, interviews, root cause analysis, GEMBA, project management, excellent collaboration, and communication.
Job description
This execution-focused role will follow the MTO Engineering Operations ways of working, and QA aligned best-practices to efficiently and effectively execute records through completion. This role is an on-site position based in our Boston and has a defined shift depending on the hiring manager.
The ideal candidate will have experience with investigations, root cause analysis, technical writing, validation and deviation triaging.
Shift
Sun-Weds starting at 7am [10 hour shifts with lunch]
Key Responsibilities
- Involved in deviation triage including coordination and investigational planning and event initiation
- Identify and collaborate with SMEs for triage, determine immediate actions and containment, and document initial impact assessments
- Lead investigation for manufacturing, QC, material, facility and equipment deviations including interviews, GEMBA using root cause analysis tools
- Use root cause analysis tools to lead and write quality events in cell manufacturing, quality control, material operations and facility operations functional areas
- Collaborate with subject matter experts on investigations to determine root cause and propose appropriate corrective and preventive actions
- Own, drive and manage CMC CAPAs and change controls from initiation, assessment and planning, execution, and closure
- Actively own and drive QE records (deviations, CAPA, Effectiveness Check, change control) in electronic Quality Management System (eQMS). Ensure all timelines and due dates are achieved
- Promote MTO and QA-aligned compliance best practices established by MTO and QA leadership
- Tracking of deliverables and timely escalations in MTO project management tool (Smartsheet)
- Other duties and projects as assigned to meet departmental requirements and manufacturing timelines
Qualifications
- Senior Level: Any Degree with 5+ years engineer, project management, pharmaceutical experience - Experienced in fast-paced environment
- Mid-Level: Engineering or Relevant Degree with 2-5 years' work experience - Some experience in industry desired
- Junior Level: Engineering Degree with 0-1 year experience - Eager to learn about the industry
Requirements
- Experience with investigations
- Experience with root cause analysis
- Technical writing experience
- Validation experience
- Deviation triaging experience
- Engineering or relevant degree
- 2-5 years' work experience for Mid Level
- 5+ years engineer, project management, pharmaceutical experience for Senior Level
- 0-1 year experience for Junior Level
Benefits
- Overtime pay eligible
Company overview
Vertex Pharmaceuticals is a global biotechnology company headquartered in Boston, Massachusetts, founded in 1989. The company specializes in discovering, developing, and commercializing transformative medicines for serious diseases, with a primary focus on cystic fibrosis (CF). Vertex has pioneered breakthrough therapies including TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, ORKAMBI, and KALYDECO, which collectively treat approximately 90% of CF patients. Beyond CF, the company has expanded its portfolio to include treatments for sickle cell disease, transfusion-dependent beta thalassemia, acute pain, and has robust clinical pipelines in APOL1-mediated kidney disease, type 1 diabetes, myotonic dystrophy type 1, and alpha-1 antitrypsin deficiency. Vertex employs approximately 6,100 people globally and maintains research facilities in San Diego, California, and Milton Park, Oxfordshire, England. The company is publicly traded on NASDAQ (VRTX) and is recognized as one of the industry's top workplaces, consistently earning accolades for its innovative culture and patient-focused approach to drug development.