Head of Engineering

Location
Medford, MA
Posted
Jul 22, 2021
Ref
1252
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time

ABOUT GREENLIGHT

GreenLight Biosciences is an integrated life sciences company developing safe and effective products that address critical problems facing plant health, human health, and animal health. Through scientific imagination and determination, we are developing products to create a future with a cleaner environment, healthier people, and a stronger food supply chain. At the core of the company’s rapid growth is a proprietary platform for higher quality RNA production at a lower cost and faster speed than has ever been possible. 

 

At GreenLight, we believe inclusion is the way forward. We celebrate the power of working together to address humanity’s challenges, meet the needs of underserved populations, and push the boundaries of scientific discovery. Fueled by our aspiration for a true sense of belonging, our talented teams embody the principles of diversity and equality as we strive to bring food security, medicine, and healthcare to everyone—paving the way for a sustainable future. For more information, visit www.greenlightbio.com.  


POSITION SUMMARY

As the leader of the Human Health Engineering & Capital Team, the Sr. Director/VP of Human Health Engineering is accountable for strategic planning and management of Engineering, Qualification/Validation, Maintenance/Facilities, and Capital Projects.  This leader will work cross-functionally to design, build/retrofit, and startup global RNA GMP manufacturing facilities aligned with GreenLight’s vision and long-term objectives.

This individual is accountable for ensuring cross-company functional alignment on project deliverables and timelines of varying complexity to meet safety, quality, schedule, and cost objectives. The role will include close collaboration and coordination internally, as well as external EPC and other 3rd party vendor partners.  Proven matrix management skills will be essential to success.

Prior experience in proven track record in pharmaceutical operations is required.  The ideal candidate will have a deep understanding of process development, equipment/facility design, construction, and commissioning.

This is a high-profile role requiring broad technical expertise and a result driven leader with exceptional people leadership skills, with the ability to influence strategic direction, develop and execute plans and inspire others to achieve desired results.


MAJOR RESPONSIBILITIES

  • Design, build, and lead Engineering fuction to deliver company objectives, including internal and external resources, as needed 
  • Develops and manages strategic plans for all engineering functions including budgets, organizational design, talent development, and other key objectives.
  • Lead strategic and detailed planning and design for cGMP manufacturing capacity, influencing company decisions based on detailed analyses.  Clearly communicates progress versus plan and spend to date for capital programs and other engineering objectives.
  • Lead all aspects of capital investment, from conceptual design through validation.
  • Oversee external engineering and design teams, as well as internal resources.
  • Develop and deliver capital project proposals to address complex manufacturing issues.
  • Lead efforts within Engineering, Process Development, Operations, Quality and Validation departments using Good Engineering Practices to develop requirements and recommendations for new manufacturing systems and modifications to existing systems.
  • Provide expertise in process engineering, design, and project execution for facility startup and manufacturing activities. 
  • Identify and deliver equipment design and facility capital projects, greenfield and improvement.
  • Primary interface and management of 3rd party partners and vendors (EPC partners, equipment vendors, SU vendors, new technologies, etc.).  Close interaction with procurement.
  • Perform facility fit evaluations for new manufacturing sites. 
  • Review and author CMC regulatory documentation for equipment, facilities-related activities. 
  • Lead projects comprised of multiple interdisciplinary groups (Manufacturing, Quality Assurance, Quality Control, Process Development, Validation, Automation, Facilities, etc.)
  • Ensures robust day-to-day support of all areas- facility, equipment, utilities, etc. Responsible for all validation teams and their tasks- cleaning validation, process validation, equipment/facilities.

QUALIFICATIONS

  • BS or MS in Chemical/Mechanical/Biological Engineering 
  • 12+ years of experience in pharmaceutical operations, including proven experience in process engineering, equipment/facility design, building/facility start-up.
  • Thorough knowledge of design, specification, validation, and operation of equipment and systems associated with cGMP operations.
  • Experience with single-use equipment and systems
  • Demonstrated history of working independently and managing multiple projects.
  • Demonstrated learning agility.
  • Experience leading or supporting commissioning and qualification-related activities such as FAT, SAT, and IQ/OQ with proficient knowledge of cGMPs and GDP.
  • Experience with scale-up/scale-down and tech transfer
  • Self-reliant, a good problem solver, and results-oriented
  • Demonstrated success and desire to work with a diverse team in a fast-paced environment under challenging timelines.
  • Must be willing to work a flexible schedule with travel required. 


Greenlight Biosciences Inc. 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.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.