- BeOne Medicines (Pennington, NJ)
- …biochemistry, biotechnology, biology, chemical engineering and/or related discipline. + Expert level knowledge in Drug Product aseptic filling operation ... **Essential Functions:** + Serve as MST DP Subject Matter Expert (SME) and process lead for drug...Oversee execution of PPQ and related activities + Support engineering teams on equipment selection, qualification, and start up… more
- Stanford Health Care (Palo Alto, CA)
- …shifts with a rotating on-call schedule, all supported by a collaborative and expert team. With access to cutting-edge equipment and a strong culture of mentorship, ... Drainage (VAVD) and Kinetic Assisted Venous Drainage (KAVD) + Maintains aseptic technique in assembling and operating perfusion equipment. + Follow manufacture… more
- Genentech (Hillsboro, OR)
- …systems, microbiology, and sterility assurance. + You possess knowledge of scientific and engineering principles relevant to Aseptic Process & Equipment, ... support the Process & Compliance team and serve the broader Aseptic Operations Manufacturing organization by driving business process improvements that… more
- Amgen (Thousand Oaks, CA)
- …at Amgen, Thousand Oaks. Under minimal supervision, the role provides compliance and aseptic oversight to Manufacturing and Facilities & Engineering staff in the ... Quality organization's main point of contact and subject matter expert for all topics related to aseptic ...with our colleagues in Manufacturing, Supply Chain, Facilities and Engineering and Automation to maintain our strong culture of… more
- Nestle (Anderson, IN)
- …are in search of a highly motivated automation professional to join our regional Aseptic Engineering Team. The right individual is recognized as a subject matter ... expert in E&A engineering . This role brings a...will maintain focus on the core objective of the Aseptic Engineering team; To act as a leader… more
- Lilly (Raleigh, NC)
- … Process related to Aseptic Processing controls inclusive of Aseptic Process Simulations, Barrier System Management, Cleaning and Disinfection, Aseptic ... and regulatory requirements related to Aseptic Processing requirements inclusive of Aseptic Process Simulations, Aseptic Technique and Barrier system (eg… more
- Lilly (Indianapolis, IN)
- …(GFD), development sites, as well as external manufacturing organizations and alliances. This Aseptic Process Engineering position serves as a technical ... as Equipment Preparation, Formulation, Filling, Freeze Drying, and Isolation systems, providing expert process engineering support globally. Parenteral sites… more
- Fujifilm (College Station, TX)
- …(FLBT) plays a crucial role under the guidance of the Vice President of Engineering andwill provide technical and process ownership for all aspects of clinical ... knowledge that can support development/review of SOPs and applicable documentation. + Expert knowledge in transferring aseptic parenteral filling and finish… more
- United Therapeutics (Research Triangle Park, NC)
- …or developing a member of your team. The Associate Director, QA Engineering will provide advanced support and subject matter technical expertise and utilize ... and support the new product development activities through product and process development and improvement, implementation of product/ process verification,… more
- Jabil (Hunt Valley, MD)
- …Ensure robust training and development programs for validation staff. + Oversee the aseptic process simulation (APS) program to ensure compliance and readiness ... the Master Validation Plan of aseptic and non- aseptic processing. + Provide strategic direction to process...process validation strategies, serve as the Subject Matter Expert (SME) to support inspections/audits by third parties (eg,… more
- JBT Corporation (Lakeland, FL)
- …services. You will report to the Senior Manager of Innovation. + Provide Process Authority validation and support services for aseptic processing and filing ... audits, facility audits, process design and optimization, product/ process assessments. + Teach courses on aseptic ...Support New Product Development projects as the Subject Matter Expert for Aseptic processing and filling technologies.… more
- Lilly (Indianapolis, IN)
- …and tomorrow. + The Sterilization Network Leader is the subject matter expert for the global sterilization program andwill provide global technical leadership for ... across the parenteral and API networks, including TS/MS, QA, Regulatory and Engineering , both site and central. + Through this global interaction the Sterilization… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …matter expert is preferred. + Technology transfer and equipment / process validation experience of aseptic , parenteral fill/finish operations preferred. + ... design, installation and qualification.Acts as fill / finish subject matter expert (SME), coordinating with Combination Products, Validation and Quality Assurance… more
- Actalent (St. Louis, MO)
- …purification and filtration/HPLC, including propagation of mammalian cell culture, aseptic cell culture operations, and execution of large-scale production ... controls and calibrators, completing batch records following cGMPs. + Perform in- process assays using equipment such as spectrophotometers, pH meters, and clinical… more
- PCI Pharma Services (Bedford, NH)
- …the future of PCI. We're looking for a **hands-on, highly skilled Principal Process Engineer** to lead complex engineering projects from concept to completion. ... and manufacturing systems for maximum efficiency and reliability. + **Own the Process ** - From URS and risk assessments to vendor management and factory/site… more
- BeOne Medicines (Pennington, NJ)
- …automated inspection machines. + Expert level knowledge in IQ/OQ/PQ and process engineering + Expertise in late stage/commercial Drug Product technology ... / Control Systems + Deviation Assessments / Investigations + SAP, LIMS, CMMS, Veeva + Expert level knowledge in all Drug Product aseptic filling operation + … more
- J&J Family of Companies (New Brunswick, NJ)
- …leadership responsibilities. The Bio-Therapeutics Technical Lead is responsible for providing expert engineering technical support and guidance; in the key ... Develop new engineering standards for facility design for Bio-Therapeutics. + Provide expert engineering technical support and guidance; in the key areas of… more
- Kelly Services (Houston, TX)
- Scientist I, Upstream Process Development-Houston, TX Kelly Science & Clinical is seeking an Upstream Process Development Scientist I to support one of our ... cell culture (sampling, cell counting, passaging). + Support upstream process development across multiple scales (shake flasks, rocker, 2L-50L bioreactors).… more
- Actalent (St. Louis, MO)
- …bulk reagents per manufacturing procedures with limited supervision. + Engage in process improvement projects and perform in- process assays using various ... setting, or related field. + Experience with cell culture, chromatography, and aseptic techniques. + Knowledge of cGMP practices and chemical concepts. + Bachelor's… more
- Merck (Wilmington, DE)
- …chromatography, tangential flow filtration and filling. + Execute the Engineering Batches, Process Performance Qualifications and commercial manufacturing. ... care. Whether you're an engineer, scientist, operator, or quality expert , your work here will contribute to life-changing therapies...out the following:** + Lead and engage with the engineering design firm in detailed design on all aspects… more
