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. Your Opportunity As a key member of the MSAT team, the Senior Engineer, Corporate Validation manages/provides technical supports for commissioning, qualification and validation (CQV) activities related to manufacturing process, production equipment, and critical utility systems for domestic and oversea locations as well as relevant external CMOs. These will encompass new facility/equipment, shipping validation, process/equipment changes and modifications, cleaning, sterilization, gamma irradiation and periodic requalification/revalidation. The incumbent will direct/support/prepare the development of project plans, protocols, test scripts and reports throughout all stages of validation from initiation to continuous monitoring. The incumbent will work with functional area representatives and equipment supplier to finalize validation requirements for process, equipment and systems, ensuring that company policies and procedures, applicable regulations and guidelines are followed during project execution and validation life cycle. Furthermore, the incumbent executes validation activities, manages contractor and coordinates with other departments. Duties and Responsibilities: Lead/support the qualification of manufacturing equipment, facility and critical utility systems. Lead/support validation of cleaning (CIP and manual), shipping, and sterilization (steam and dry heat) processes. Provides guidance to junior full-time employees and contracted personnel performing validation activities. Define scope of work and bid out project, as needed. Manage the development and execution of FATs, SATs, DQ, IQ, OQ, PQ and other relevant validation life cycle documents, such as commissioning plans and test scripts, commission summary reports. Manage/support the development of master plans, validation plans, SOPs, system impact assessments, criticality assessments, risk assessment and validation protocols for new facility/equipment, new functionality/process, process/equipment changes and modifications, and periodic requalification/revalidation. Support development of overall validation strategy, programs and policies, Master Plans, and SOPs pertaining to governance of validation lifecycle. Coordinate independently and directly interface with personnel from multiple departments including Product development, Manufacturing, Engineering, Facilities, and QA/QC. Support corrective actions including investigating and resolving deviations as relevant to validation. Qualifications: Bachelor's Degree or higher in Engineering, Life Sciences or related disciplines. Hands on experience in developing validation plans/protocols, field execution, and preparing validation final reports. Expertise in Shipping Validation. Expertise in one or more of the following areas are required: Facility/Equipment/Utilities Qualification, Cleaning Validation, Sterilization Validation, or Media Fill. Expertise in Process Validation is a plus. Highly knowledgeable in both domestic and international GMP regulations (FDA and EMA) and industry guidance documents (e.g. ICH, PDA, ISO, PIC/S, and ISPE), and incorporate continuous improvements and best industry practice into validation activities and policies. Hands on experience with regulatory inspection is a highly desirable. Knowledge of Automation Software Validation is a plus. Strong understanding of risk-and science-based validation approaches is desired. Experience with system and process risk assessments; including FMEA, and HAZOP. Knowledge of drug/device combination products is highly desirable. Project planning experience is a plus Skills: Demonstrated knowledge of pharmaceutical manufacturing of sterile products, or aseptic processing, and/or drug/device combination product manufacturing Must demonstrate the ability to think critically and analytically, including ability to demonstrate trouble-shooting and problem-solving skills Strong interpersonal, follow up, and verbal and written communication skills Ability to function efficiently and independently in a fast-paced, changing environment Read and interpret drawings such as blueprints, AutoCAD, P&ID. Expert Microsoft Word and Intermediate Microsoft Excel skills are required Strong team player aligned with Intarcia Corporate Values Experience: 10+ years (7+ years for Senior Engineer, 5+ years for Engineer III) of relevant validation experience. For Senior Manager, need 5+ years of experience in managing others Aseptic process experience is a must Experience with Fill/Finish process and isolator technology is high desirable 5 to 7 years of hands on qualification experience in a cGMP environment (IQ, OQ, PQ) is required (No relocation/Local candidates only) Associated topics: bio, biochemistry, biology, biomechanics, biomedical, biosynthetic, enzyme, metabolic, parenteral, pharmaceutical
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