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.
As a key member of our Facilities Engineering & Maintenance team, the Utilities Engineer is responsible for providing technical, compliance, and performance oversight of the utility systems serving the manufacturing environment. These systems including HVAC, building automation system (BAS), clean dry air (CDA), chilled water, cooling water, heating hot water, nitrogen, power distribution, RODI water, steam, clean steam, Water for Injection (WFI), and wastewater and exhaust treatment systems.
The role reports to the Associate Director of Facilities Engineering and Maintenance, and will represent critical utility systems to auditors, partners and project teams, working closely with other technical functions, consultants, and contractors as required.
The Utilities Engineer will ensure utilities are maintained compliant with the latest regulations and meet safety, quality, productivity, operability, reliability, and cost drivers. The Engineer will raise our overall performance through technical improvements, ensuring our validation and environmental permit status is always maintained.
Duties and Responsibilities:
- Acts as technical expert to train and coach facility technicians on preventive and corrective maintenance methods and procedures.
- Accountable for technical systems documentation (P&IDs, URS, FS, FAT/SAT, Commissioning, IOQs, SOPs, data sheets, material and equipment specifications, etc.)
- Ensures the utilities PM program is properly documented, executed, and the appropriate CMMS data, including spares and task lists, is available.
- Leads utilities technical investigations, CAPAs, and change controls, supporting the EHS and QA teams collaboratively to ensure compliance with all government regulations, site standards, and programs.
- Collaborates with project teams throughout capital project lifecycles to ensure utilities engineering scope is challenged, sustainable, reliable, and designed for maintainability.
- May perform hands-on activities in operations, ranging from equipment/systems setup, inspection, and support to maintenance.
- A Bachelor’s degree in Engineering or equivalent
- 6-8years of pharmaceutical manufacturing experience in a technical function
- Fluency with cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices
- GMP utility systems qualification experience in a cGMP environment (IQ, OQ, PQ) is required
Skills and Experience:
- Demonstrated knowledge of critical 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.
- Good interpersonal, follow up, and excellent verbal and written communication skills.
- Ability to function efficiently and independently in a fast-paced, changing environment.
- 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.
For more information visit www.intarcia.com.
(No relocation/Local candidates only)