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Sr. Specialist, Process Engineering

Company: Vertex Pharmaceuticals, Inc
Location: Boston
Posted on: June 13, 2021

Job Description:

Job Description

Vertex's Manufacturing Technical Services (MTS) team in GMP Operations at the Vertex Manufacturing Center (VMC) has an exciting opportunity for a Senior Specialist leading process and equipment engineering projects and contributing to project management at the VMC. Vertex has installed a state-of-the-art GMP manufacturing facility in Boston at the VMC, less than a mile from the Corporate Headquarters in the Seaport District. This GMP facility is a keystone to delivering our strategy of bringing transformative medicines to patients in need, from clinical development to commercialization. This GMP facility encompasses drug substance manufacturing in the Kilo Lab (KL) and drug product manufacturing in the Drug Product Facility (DPF), as well as an analytical Quality Control (QC) release and stability laboratory. The site also houses the first FDA and EMA approved fully continuous drug product manufacturing rig, the Development and Launch Rig (DLR).

The Process Engineer/Specialist will be highly motivated to cultivate a culture of efficiency, effectiveness, and compliance while coaching and leading staff through a transformative time at the VMC as we expand the footprint, capabilities, and capacity of the manufacturing site.

The Process Engineer will work collaboratively across departments to ensure a state of compliance exists within the VMC, contribute to trouble-shooting and assist in driving continuous process/equipment improvements.

Responsibilities:

  • The primary responsibility of this role is contributing to process and equipment engineering projects at the VMC, including working with cross-functional resources working on these projects. More specifically, this individual will:
  • Collaborate with and assist the MTS Senior Manager of Process Engineering on all process and manufacturing-related engineering projects and continuous improvements at the VMC.
  • Lead root-cause investigations and CAPAs for process and manufacturing-related events at the VMC, including developing corrective action plans and relevant documents to resolve deviations.
  • Support the MTS Senior Manager of Process Engineering in all cross-functional team projects at the VMC focused on manufacturing, including:
  • Process/equipment upgrade projects, including development of 3D detailed design drawings, coordinating quotes from vendors and project management to implementation;
  • Advanced manufacturing initiatives, including 3D scanning of parts and coordinating/managing process modeling, implementing predictive maintenance programs;
  • Assist team manager with project management tasks, including data analysis, preparation of team presentations, collection and summary of meeting notes.

Requirements:

  • Bachelor's or Master's Degree in a pharmaceutical science or engineering discipline, preferably chemical or mechanical engineering
  • 4-6 years experience in a GMP manufacturing facility
  • Understand cGMP concepts and general practices
  • Experience in Solid Oral Dosage manufacturing, including continuous and batch pharmaceutical manufacturing as well as analytical techniques that support manufacturing activities.
  • Demonstrate good communication skills both oral and written
  • Present study information to internal Group/Department meetings on areas of expertise
  • Technical Expert for data review and interpretation, preferably with experience using SAS JMP and/or MiniTab
  • Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
  • Experience analyzing and designing process equipment, including use of 3D drafting programs (SolidWorks, AutoCAD 3D) and development/review of fabrication drawings.

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.

Keywords: Vertex Pharmaceuticals, Inc, Boston , Sr. Specialist, Process Engineering, Other , Boston, Massachusetts

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