- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of ... in quality assurance, manufacturing compliance, clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will serve as the business process ... quality systems processes.Ensure compliance with current Good Manufacturing Practices ( cGMP ).Manage multiple and complex cross-functional projects with many stakeholders.Support… more
- Mercer County Community College (Princeton Junction, NJ)
- …Engineering from an accredited institution. Two (2) years of experience in an aseptic manufacturing facility. Knowledge of cGMP regulations and FDA/EU guidance ... in a classroom or corporate setting. Curriculum and module design experience. Experience in aseptic cleaning or GMP cleaning, or titles such as Cell Processing… more
- Tolmar (Fort Collins, CO)
- …shift, Monday - Friday 6:00 am - 2:30 pm Purpose and Scope The Aseptic Lead Operator supervises and leads processes including set-up and operation of processes ... gowning, including but not limited to: Company-provided Scrubs Shoe Covers and Sterile Boot Covers Hairnets (and beard covers as applicable) Tyvek Coveralls Gloves… more
- Alcami Corporation (North Charleston, SC)
- …perform assigned duties and tasks. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Assists with applicable ... areas as required. Other duties as assigned. Manufacturing Technologies for Sterile Liquids: Equipment and component preparation and sterilization Compounding … more
- Kelly Services (West Chester, OH)
- …pharma/life sciences industry (healthcare or food manufacturing acceptable) + **Understanding of GMP / cGMP / sterile / aseptic production** - proven success ... drive success in this vital role. Looking for experience in pharmaceutical manufacturing with GMP experience. Temp to hire opportunity! Mon - Friday 1st shift - can… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …aseptic cleaning, equipment preparation for sterilization, product pathway assembly, sterile filtration, aseptic filling and terminal sterilization. + ... Sterile Injectable Supervisor Department: Production Location: Monroe, NC...Degree preferred Experience: 5 - 7 Years- experience in CGMP / Aseptic Operations Background Knowledge & Skills: +… more
- Endo International (Rochester, MI)
- …all equipment in the department for the purpose of cleaning and disinfecting/sanitizing/fogging aseptic and non- aseptic GMP areas ▪ Maintains supplies and ... containers for sterile filling production waste. ▪ Documentation ▪ Documents GMP records, LUMAC logbooks and sanitation schedules, upon completion of daily work… more
- Merck (West Point, PA)
- …SPO Technician | Level 1 completes a wide variety of tasks and operations in GMP , aseptic and controlled environments that are required to support and execute ... maintenance and repairs as assigned for the equipment and facilities within Sterile and Packaging Operations + Conducts cleaning requirements as assigned in the… more
- Catalent Pharma Solutions (Harmans, MD)
- …and people development. + Highly experienced in Bio pharmaceutical manufacturing and/or aseptic processing working in a GMP environment. + Advanced experience ... Sterility Assurance,** will be responsible for quality assurance oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for… more
- Sanofi Group (Swiftwater, PA)
- …of quality experience in a GMP -regulated environment. + Accessing aseptic processing areas, sterile gowning, exceptional eyesight, sampling technique, detail ... levels. + Provide daily floor coverage to support compliance of production ( aseptic processing areas ( sterile gowning a prerequisite), development, and testing… more
- Novo Nordisk (Bloomington, IN)
- …what matters. Primary - Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment preparation, product formulation, ... material staging, and aseptic filling. Product in this area is filled into...area is filled into vials, syringes, or cartridges inside sterile isolator barriers. The sterile barrier isolator… more
- ThermoFisher Scientific (Greenville, NC)
- …facility). + Experience in a pharmaceutical quality function, preferably in a sterile manufacturing site. + Detailed knowledge of aseptic processing, and ... (Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Office **Job Description** **GROUP/DIVISION SUMMARY** The… more
- Bristol Myers Squibb (Indianapolis, IN)
- …complaints, deviations, investigations, and CAPA management. + Experience working in aseptic / sterile environments and/or in quality control operations focused on ... The Operations Quality Assurance team is responsible for Quality collaboration and GMP /GDP oversight of operations at CDMOs and at Internal site operations,… more
- Novo Nordisk (Bloomington, IN)
- …what matters. Primary - Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment preparation, product formulation, ... material staging, and aseptic filling. Product in this area is filled into...area is filled into vials, syringes, or cartridges inside sterile isolator barriers. The sterile barrier isolator… more
- Unither Pharmaceuticals (Rochester, NY)
- …With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees. ... manufacturing and packaging operations using suitable instrumentation according to cGMP 's. Supports laboratory to ensure laboratory procedures, equipment, supplies,… more
- Catalent Pharma Solutions (Harmans, MD)
- …technology; + Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injectable products manufactured by aseptic processing; + Knowledge ... **Principal Engineer, Equipment Aseptic Filling** **Position Summary:** Catalent, Inc. is a...of quality and service. Catalent provides process development and GMP manufacturing services for Phase I/II clinical trials to… more
- Curia (Albuquerque, NM)
- …conversational noise in the background. The pharmaceutical manufacturing environment is sterile . Therefore, aseptic gowning is required. Personal protective ... equipment, processes, utilities, systems, and components in alignment with cGMP regulations, internal procedures, and applicable regulatory expectations. This… more
- Unither Pharmaceuticals (Rochester, NY)
- …With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees. ... equipment. Executes all Production processes while strictly adhering to cGMP , Standard Operating Procedures, documentation protocols, environmental health and safety… more
- Curia (Albuquerque, NM)
- …and vial sealing) of parenteral products according to Current Good Manufacturing Practice ( cGMP ) in an aseptic environment. This role will train, coach/develop, ... enhance production processes and efficiency. The position also involves sanitizing aseptic and controlled areas using specialized solutions and equipment, following… more
