Intarcia is rethinking medicine with the potential to unlock significant change in the way serious chronic diseases or conditions are treated - starting first with Type 2 Diabetes, and then, obesity and HIV. To date, the company has raised more than $1.8B in capital through creative financing and partnerships - including our collaboration with the Bill and Melinda Gates Foundation for HIV prevention in Sub-Saharan Africa. Intarcia headquarters are in Boston, MA with manufacturing and R&D locations respectively in Hayward, CA and Durham, NC.
Intarcia is committed to developing innovative therapies utilizing the Medici Drug Delivery System which is designed to bridge technology and medicine to transform therapeutic categories. The matchstick-sized osmotic mini-pump is subdermally placed and delivers a continuous flow of medication over the course of months, working with the patient's own body. This approach is designed to support adherence and allow individuals to focus on more fully living their lives.
Intarcia Therapeutics is seeking a Principal Facilities Engineer to support facilities and utilities operations and maintenance focusing on day-to-day coordination and monitoring of activities, audit/inspection support as well as driving infrastructure related projects. The role is within the Corporate Engineering organization and reports to the Director of Facilities Engineering & Maintenance.
Duties and Responsibilities:
Support the Director, Facilities Engineering & Maintenance with responsibilities related to 24x7 system performance and leadership of junior engineers where appropriate.
Support audits and inspections by representing the service and operations performed in all capacities, either independently or with other Subject Matter Experts (SME's).
Represent the department in support of Corporate Engineering projects, performing documentation reviews, coordinating departmental support where warranted, performing design and constructability reviews, job walks, and turnover package requirements.
Drive improvements in operational efficiency through analysis and an in-depth understanding of production and maintenance schedules, site specifications and utility/facility capacities.
Develop and present mid and long-term assessments of facility/utility capability, capacity and useful life in preparation of site requirements and maintenance budgets.
Set up and drive facilities & utilities projects, determining priority, timeline and funding, while ensuring compliance with Safety, Environmental and Quality requirements
Work with outside resources, including architects and engineers, as well as internal resources in developing project design and execution plan.
Develop, submit and present requests for funding and justification documentation.
Support the execution of facilities and utilities operational activities through the analysis of costs in relation to reliability and labor/materials expended to achieve reliability.
Support the planning and execution of semi-annual Extended Maintenance Period (EMP) activities through project coordination and field activities.
Author Standard Operating Procedures (SOPs), Work Practices, Guidance Documents, Job Plans, and Data Sheets, ensuring compliance with Company policies and applicable regulations.
Performs or oversees hands-on activities in facilities and utilities operations, ranging from setting up and running equipment, inspection of parts, and maintenance.
Support the training, coaching, and development of facilities technicians and junior engineers, ensuring quality and safety behaviors are adopted by the team, and audit logbooks and other records for Good Documentation Practices.
Ensures external resources supporting facility and utility systems are performing in accordance to company expectations, vendor qualifications, and performance requirements.
Support the continuous improvement of maintenance, calibration, and MRO spare parts programs, by assessing and helping develop the utility/facility maintenance strategy.
Ensure equipment records are available and maintained (e.g. drawings, manuals, files).
Performs investigations and Corrective Actions/Preventive Actions (CAPAs), as assigned.
Bachelor's degree in Electrical, Electronics, Electromechanical, Mechanical, Mechatronics engineering or related discipline. Equivalent experience may be accepted.
Greater than 10 years of technical experience in a GMP manufacturing environment (Aerospace, Nuclear is acceptable).
Demonstrated familiarity with cGMP manufacturing and regulatory requirements for pharmaceuticals and medical devices.
Must be proficient using computers & software programs such as MS Word, Excel, Outlook, Explorer, etc.
Experience using MAXIMO asset management software is desired.
Available to work on call to address instrument failures or workload peak demands.
Must be able to communicate effectively with other co-workers, contractors, and inspectors.
Ability to visually and mechanically inspect machinery and systems.
Ability to frequently walk up and down stairs for inspections and emergency procedure practice or implementation.
Ability to detect emergency alarms - auditory and/or visual.
Physically able to operate electric hand tools, climb/work on a ladders (up to 40 feet), carry tools, lift and carry heavy loads (up to 60 lbs), and operate a motor vehicle.
Equipment inspections require getting on hands and knees to reach areas difficult to access.
Demonstrated advanced knowledge of facilities and utility systems, with experience maintaining and improving systems for uptime and reliability.
Demonstrated ability to think critically and analytically; demonstrated troubleshooting and problem solving skills.
Demonstrated ability to drive projects, lead junior staff and/or contractors and meet overall objectives.
Excellent interpersonal, follow up, and excellent verbal and written communication skills.
Ability to function efficiently and independently in a fast-paced, changing environment, while understanding when to escalate issues.
Schedule driven and results-oriented.
Strong team player aligned with Intarcia Corporate values.
Intarcia Therapeutics, Inc. is a biotechnology company dedicated to redesigning the prevention, treatment and experience of chronic diseases including diabetes, obesity and HIV. As an organization, we are driven by a desire to create meaningful change in both business and health, rethinking how prescription medicine is delivered. Our dedicated team operates with a "No Analog" mindset-continually pushing boundaries, navigating new terrain and unleashing fresh thinking. It's all part of Intarcia's commitment to enable better outcomes and create impact. The Intarcia Medici Drug Delivery System was developed over a 20-year span in collaboration with a diverse, forward-thinking team of scientists and entrepreneurs with a goal of bridging technology and medicine to transform therapeutic categories. Based on human behavior, the Medici System is intended to relieve the burden and adherence concerns of chronic therapy by delivering prescribed medicines for six months at a time - or potentially longer. Intarcia is also investigating multiple new therapies, including combination therapies for chronic diseases leveraging the convergence of novel medicines from Intarcia's pipeline with the proprietary Medici System.