39356_Engineering Sr. Manager / Engineering Associate Director

divh2Engineering Sr. Manager / Engineering Associate Director / h2pJubilant HollisterStier LLC, Spokanes largest manufacturing company, and well-established member of the business community, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. Jubilant HollisterStier is a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is a proud member of the Jubilant Pharma family. Our promise : Caring, Sharing, Growing. We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions through growth, cost effectiveness and wise investment of resources. / ppJob Description : The Engineering Sr. Manager / Engineering Associate Director will lead a team of technical professionals responsible for the design, installation, qualification, and ongoing operational improvement of state-of-the-art aseptic filling equipment for liquid and lyophilized pharmaceutical products. This role ensures compliance with cGMP, regulatory requirements, and industry best practices while driving reliability, innovation and efficiency in sterile manufacturing operations. / ph3Project Leadership / h3pManage end-to-end engineering projects for aseptic filling systems, isolators, lyophilizers, and component preparation equipment including concept design, procurement, installation, commissioning, and qualification. / ppDevelop and maintain project timelines, budgets, and resource plans. / ph3Design Specifications / h3pDefine technical requirements for filling lines, filling assemblies, isolators, lyophilizers, component preparation equipment, product and diluent vessels and associated SCADA components. / ppCollaborate with cross-functional teams (Manufacturing, Quality, and Validation) to ensure equipment meets process and regulatory needs. / ph3Installation Qualification / h3pOversee equipment installation and integration into existing facilities. / ppLead IQ / OQ / PQ activities in alignment with validation protocols and regulatory standards. / ph3Compliance and Documentation / h3pEnsure adherence to global regulatory requirements and guidelines for aseptic processing and regulatory standards. / ppPrepare and review engineering documentation, including URS, FAT / SAT reports, and qualification protocols. / ppOwn equipment related deviation and CAPA investigation and remediation. / ph3Team Management / h3pSupervise and mentor a team of 10-15 technical engineers. / ppFoster a culture of safety, quality, and continuous improvement. / ph3Vendor Management / h3pQuality, select and manage equipment suppliers and contractors. / ppNegotiate contracts and ensure timely delivery of equipment and services. / p / div