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Job Description

Associate Director, Equipment Engineering

Vertex has established a new research site in the Boston Seaport where research, development, and clinical manufacturing for cell and genetic therapies is primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Investment in a research site specifically designed to advance these programs is key to Vertex’s continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams bring together the best biology, technologies, and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible. 

Vertex is seeking a talented individual to join our Process Development /Engineering team. This group offers a dynamic, fast-paced, and highly collaborative environment with a tremendous impact on our programs and for our patients. Our team focuses on bringing together the best of process design, scale-up and cutting-edge manufacturing technologies to enable the successful implementation of cell and gene therapeutics. 

The successful candidate will be responsible of evaluation and implementation of custom designed GMP compliant equipment used for encapsulation and fill-finish of cell therapy drug substance, drug product or combination product manufacturing.

The role will provide subject matter expertise in design, selection, and implementation of automated equipment for drug and drug-device combination product manufacturing. The candidate will work closely with Process Development, Device Research, Device Process Development, Manufacturing, and Site Engineering to enable technology transfer and implementation of state-of-the-art equipment.

Key Duties and Responsibilities:

  • Act as technical SME for equipment and process design.
  • Develop user specification for encapsulation, filling and closure equipment
  • Act as a system owner and drive the installation and qualification of such equipment
  • Leads material and component selection, design, and approval. Works with internal partners and external vendors to design, source, and implement materials.
  • Leads change parts and recipe creation for new product introduction.
  • Supports SOP development and revision for assigned equipment and process operations.
  • Drives innovation in manufacturing equipment and techniques by paying attention to latest technological advancement
  • Collaborate with other departments such as Engineering, Validation, DP Process Development, Device Research, Device Process Development, Regulatory, Quality Assurance and Quality Control
  • Designs and drives cycle development and other studies on manufacturing equipment as defined by end user needs.
  • Prepare reports and presentations to communicate technical recommendations for investments in manufacturing technologies
  • Provide Request for Proposal (RFP) inputs including Engineering requirements such as tooling, capital equipment and/or new process development
  • Mentor and train engineers and manufacturing operators on novel fill-finish technologies

Requirements:

  • Masters or PhD degree in Mechanical Engineering or relevant STEM field
  • 7+ years (PhD) or 10+ years (MS) of experience in implementing new instrumentation technologies in a Manufacturing setting

Required Knowledge/Skills:

  • Expertise in engineering principles of large-scale automated manufacturing equipment such as Capsule manufacturing or aseptic fill-finish equipment 
  • Knowledge of Isolator, RABS and containment technologies and integration of filling system in these modules
  • Experience with 3D Solid Modeling using a CAD software
  • Hands on experience in testing and prototyping new equipment technologies in development settings prior to implementation into GMP manufacturing
  • Strong mechanical sensibilities and experience 
  • Hands-on mechanical aptitude with tools 
  • Strong troubleshooting experience on automated systems 
  • Mechanical 
  • Electrical 
  • Pneumatic 
  • Programmatic
  • Knowledge of various filling technologies for suspension and liquid drug product manufacturing
  • Experience in designing change parts and components for different primary contains, vials, cartridges, bags and implantable devices
  • Experience authoring/executing/supervising FAT/SAT testing 
  • Knowledge of GMP requirements, Quality Assurance and Regulatory guidance to implement new technologies in manufacturing settings
  • Strong verbal and written communications skills with ability to effectively communicate at multiple levels in the organization through project status meetings, presentations, and reports.
  • Ability to manage a small team of engineers and scientists based on business need
  • Ability to adapt to evolving priorities and thrive in a dynamic and fast-paced environment

#LI-SV1 #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.

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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Confirmed 19 hours ago. Posted 30+ days ago.

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