at Intarcia Therapeutics, Inc.(View all jobs)Hayward, CA
Intarcia Therapeutics, Inc., is a rapidly emerging biopharmaceutical company committed to developing innovative therapies that merge medicine with technology.
At Intarcia, we seek to transform the standard of care and improve patient outcomes in major therapeutic categories for serious chronic diseases, such as diabetes. We successfully completed our Phase 3 clinical trial program for our lead product, ITCA 650, and submitted our New Drug Application filing in the U.S. in 2016.
Additionally, we are developing a pipeline of products for our proprietary Medici Drug Delivery System™, comprised of three unique technologies: 1) A stabilization technology that allows for proteins, peptides, antibody fragments, and other highly potent small molecules to be stabilized at or above human body temperatures for up to three years or more; 2) A matchstick-sized osmotic mini-pump that is placed just under the dermal layer of skin to deliver a continuous and consistent flow of medication; and 3) A placement technology including proprietary tools designed to provide an optimal user experience.
We Are Growing
Since our 2012 round of financing, much progress has taken place at Intarcia, including significant enhancements to our world-class manufacturing facility, the opening of our new headquarters in Boston’s Innovation Center, and the diversification of expertise on our Board of Directors and Leadership Team through new senior leaders who contribute vital new capabilities and experiences.
A key element of pride during our progress has been our ability to remain fully independent throughout our rounds of financing so that we continue to have full strategic and executional control over all aspects of our rapidly evolving business. While we are always accountable to our stakeholders, we are – and intend to remain – the driving vision and force behind our progress and our ultimate success.
As a key member of our Engineering & Maintenance team, the Utility Engineer is responsible for ensuring the implementation of compliant, cost-effective, and safe engineering solutions, along high quality investigations, thorough implementation of corrective and preventive actions, and effective periodic reviews, change controls and associated commissioning and qualification practices for Intarcia’s utilities and support systems. Ensures these systems are designed, constructed, installed, commissioned, qualified, and maintained according to Good Engineering Practices (GEP) and local building, fire, safety, and environmental regulations. The Compliance Engineer may lead cross-functional teams in commissioning, qualification, investigations, change controls, and re-qualification initiatives.
Duties and Responsibilities:
• Manage and coordinate the engineering safety and compliance program, including actions tracking and issues resolution.
• Develop compliance plans by researching, analyzing, selecting and applying compliance engineering options.
• Drive compliance initiatives with a solid knowledge of Cal OSHA, CCR, CBC, CMC, CPC, NFPA, NECA, ASME, and NEC applicable requirements, along with the ability to understand and advise site specific CSI specifications, machine design specifications, and design drawings including P&IDs.
• Champion compliance with engineering initiatives, policies, and guidance; developing gap assessments, remediation plans, action tracking and resolutions.
• Lead major efforts, or phases of projects, to resolve technical problems.
• Author Standard Operating Procedures (SOPs), Work Practices, or Guidance Documents to ensure compliance with Company policies and applicable regulations.
• Support regulatory submissions and regulatory agency or internal inspections.
• Lead investigations and Corrective Actions/Preventative Actions (CAPAs), as assigned.
• Manage department asset control and re-qualification activities, facilitating all pre-and post-approval cycles and Out of Service Notice (OOSN) processing.
• Develop and maintain accurate engineering compliance metrics and key performance indicators, prepare compliance reports summarizing measurement data and trends.
• Participate on projects ensuring workmanship standards are maintained in accordance with specifications. Advise and support project managers to reconcile deficiencies.
• Perform audits of contractor and vendors ensuring pre-qualification criteria, as required.
• Bachelors’ degree in an engineering or related discipline. Equivalent experience may be accepted.
• Requires 6-8+ years of industry work experience in a GMP pharmaceutical/bio-pharmaceutical manufacturing environment
• Strong problem-solving and organizational skills
• Ability to learn new technology quickly
• Extensive experience in leading investigations and implementing CAPAs. Participation or leadership in complex investigations is a plus.
• Possess in-depth knowledge of GMP and safety regulations related to facilities and equipment, including commissioning and qualification of utilities, manufacturing and laboratory equipment
• Strong oral and written skills
• Ability to manage, organize and troubleshoot complex technical problems and drive resolution
• Experience working in a dynamic engineering environment with real-time crisis management skills
• Confident with navigating ambiguity and creating new ways of doing things