Process Development Engineer (V013)

  • Contract Duration: Through 2021, with potential to extend/convert
  • Manufacturing
  • Providence, RI

Website Lenox Executive Search


Onsite contract through 2021, with potential to extend/convert.  In June 2019, the company announced the establishment of new research sites in Boston and Providence where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat—and even cure—several of the diseases the company is focused on, including sickle cell disease, Duchenne muscular dystrophy, and Type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to the company’s continued and sustained leadership in these exciting approaches. Our research teams will 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.

The company is actively recruiting for a Process Development Engineering Scientist II. Reporting to the Associate Director of Process Engineering, this role will focus on the development of implantable cell encapsulation devices for delivering proprietary cells. The successful candidate will join the Process Development Team and work on process development, optimization, process scale-up, and technology transfer of novel products and processes into Manufacturing. The position will be located in Providence, R.I.

Key Responsibilities:

  • Design and development of equipment, processes, and control systems, used for production and assembly of cell encapsulation devices.
  • Manage the evaluation and selection of new equipment/technologies or modifications to existing systems to consider new processing technologies.
  • Support ongoing optimization and improvement in equipment/systems/processes for long term robustness and reliability.
  • Establishes operating specifications, defines process windows, and improves manufacturing techniques/processes.
  • Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
  • Responsible for writing and reporting of Protocols, Reports, SOP’s and Work Instructions, as required, and conducts or coordinates testing and execution of identified activities.
  • Statistically characterizes processes and implement controls to ensure repeatability and consistency.
  • Design 3D CAD models, create drawings and collaborate with vendors to produce prototype and production parts. Perform engineering analyses and relevant physical testing on designs.
  • Provide hands-on, troubleshooting, process, and manufacturing assistance in support of a rapid development cycle and manufacturing sustainability.
  • Execute assigned duties on time and within budget; pro-actively telegraph delays and other issues to relevant stakeholders.
  • Comply with all regulatory, corporate, and Quality System policies and complete other projects and/or assignments as required.
  • Support Deviation Management, C.A.P.A., and Change Control activities, as required.
  • Comply with all Regulatory, Corporate and Quality System policies.
  • Performs other duties as assigned.

Required Qualifications:

  • B.S or M.S in engineering or another relevant discipline.
  • 8+ years of experience (5+ years with Masters) working on process development and optimization within a medical device environment.
  • Understanding of c.G.x.P principles and practices and familiarization with ISO 13485, ISO 14971, and 21C.F.R.820 is a plus. Knowledge of global GMP requirements governing device or combination products.
  • Experience with 3D CAD software, preferably with Solidworks, is preferred.
  • Experience with EtO Sterilization, sterilization validation, and familiarity with ISO 11135 is desirable.
  • A strong understanding of statistical principles is required, as are strong technical writing and presentation skills.
  • Hands-on approach to problem solving, risk identification and resolution.
  • Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
  • Sense of urgency, ability to act/escalate promptly, and transparently communicate issues to involved stakeholders and management.
  • Must demonstrate strong interpersonal, presentation, and teamwork skills.
Upload your resume here.

Our COVID-19 Policy

As with other larger employers and customer-facing organizations, Lenox Executive Search is carefully monitoring the situation regarding Coronavirus (COVID-19), with a particular focus on public health guidance offered by the CDC and state officials.  We are reaching out to make you aware of our activities and preparations in light of the spread of the Coronavirus (COVID-19). Our number one priority is the safety of our employees, clients and the broader community. Given the current unpredictable nature of the spread of COVID-19, and in an abundance of caution, Lenox Executive Search has implemented the following practices immediately:
  • We have increased our overnight cleaning activities to ensure frequently touched areas are being disinfected and sanitized.
  • We have implemented social distancing techniques to minimize the typical face-to-face- contact by utilizing teleconference calls and flexible workspaces.  We have suspended non-essential business travel for our employees and have asked that inter-company meetings be conducted via teleconference. In addition, we kindly ask all of our customers to help us maintain a handshake-free zone at all Lenox Executive Search locations.
  • We have asked employers who feel ill to stay home.
  • We have convened a team of senior leaders who meet daily to discuss the situation and stand ready to take additional steps, if necessary.
  • We have measures in place to ensure our operations can effectively continue so that we can provide our clients uninterrupted service.  Lenox Executive Search already had robust and detailed business continuity plans in place.
– The Lenox Executive Search Team