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Principal Systems Engineer

4 months ago

Cumberland, United States NEUROTECH U S A Full time
Job DescriptionJob Description

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI, within the realm of Greater Boston’s vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary biological drug device combination technology for treatment of a variety of retinal disorders. Our most advanced program is developing a treatment for the orphan disease Macular Telangiectasia Type 2 (MacTel). Our Encapsulated Cell Technology (ECT) platform is designed to deliver a genetically modified neuroprotective factor to slow the progression of this chronic retinal disease.

We are seeking a highly motivated Principal Systems Engineer who thrives in an innovative and fast-paced small company environment and efficiently communicates and collaborates across functional areas. The successful candidate will play a key role in the development of a vertically integrated Engineering Technology team to optimize and validate manufacturing process equipment and process systems supporting commercial approval of our clinical Phase III therapeutic product.

This is an on-site role in Cumberland, RI. This is not a hybrid or remote opportunity.

Also, please note this role is not eligible for agency recruiting support.

Job Requirements

  • Be a System Owner and lead a cross-functional engineering team through the new product development and validation process of automated manufacturing equipment.
  • Collaborate with mechanical, electrical, software, and process engineers to define system requirements, sub-system features, and program schedule and work breakdown structure.
  • Responsible for all system level documentation for Good Manufacturing Practices (cGMP) class of GAMP5 computerized systems design and validation.
  • Solve process equipment issues using best-in-class tools such as troubleshooting matrices, fishbone diagrams, FMEA and other structured problem-solving methods.
  • Identify and mitigate risks associated with device functionality, reliability, safety, COGs and manufacturing scalability
  • Optimize unit operations for improved manufacturability, and ultimately support design transfer of improved systems into a highly automated production environment
  • A demonstrable track record of success in influencing and communicating with team members and the ability to work within a global matrix environment is required.

Education & Experience

  • Requires a BS or higher degree in Electrical or Mechanical Engineering, or related discipline plus at least 8 years of experience in design of products or prototypes from a systems perspective.

Knowledge, Skills & Abilities

  • Hands-on experience with:
    • Multi-axis robot programming and integration 6-axis a plus
    • PC-based logic control (Beckhoff and TwinCAT a plus)
    • Systems wiring and integration
    • Pneumatic systems integration
    • Machine vision and vision-based precision measurement
    • Precision Mechanical assembly
    • Industrial networking and communication protocols
    • SQL Database and Historians
    • Safety system logic
    • Specifying and procuring industrial automation components
    • Solidworks CSWP or equivalent, Autocad Electrical a plus
    • Labview, Programming Ladder, C#, C++
  • Familiarity with current Good Manufacturing Practices (cGMP), and compliance issues for products manufactured by aseptic processing.
  • Excellent communication skills with the proven ability to build open and collaborative relationships and work effectively as a member of a multidisciplinary team.
  • Demonstrated ability to multitask, manage multiple stakeholder interactions and work effectively with team members in a fast-paced environment.
  • Possess presentation skills to influence and inform scientific decisions at senior management, cross-functional or external meetings.
  • Excellent interpersonal and leadership skills, including strategic planning, negotiation, and conflict management, written and verbal communication

In addition to a talented and passionate team of colleagues and unparalleled science and technology, Neurotech offers competitive compensation, benefits through Blue Cross BlueShield and HealthEquity (FSA, HSA & HRA), a 401(k) through Fidelity with a company-sponsored match, generous vacation time and company holidays. We even cover the cost of 75% of your annual medical plan deductible And that’s just the beginning.

Do you share our vision?

Applications are currently being accepted through the Neurotech Career Center.

Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Additionally, Neurotech does not accept unsolicited résumés or candidate profiles. If a candidate submitted in this manner is hired, no placement fee will be paid.