- Merck & Co. (Durham, NC)
- …for the Associate Production Technician include the execution of aseptic processing requirements, adherence to GMP (Good Manufacturing Practices), and ... weekends and holidays - Must be able to successfully pass Aseptic gowning qualification. Aseptic gowning requires that all skin and hair be covered through… more
- Merck & Co. (Durham, NC)
- …for the BCG Product. The position will focus on environmental monitoring, aseptic process simulation and support testing readiness in preparation for commercial ... Qualification activities.Microbiological testing in support of production media.Participating in aseptic process simulations, including sampling, testing of simulation units,… more
- Merck & Co. (Durham, NC)
- …working alternating weekends-and holidays--Must be able to successfully pass and maintain aseptic gowning qualification. Aseptic gowning requires that all skin ... mask, goggles, jumpsuit, gloves and boots.-Must be willing to be qualified in aseptic operations and perform operator roles as needed.-Must be willing and able to… more
- Merck & Co. (Millsboro, DE)
- …facility decontamination according to approved proceduresAssist with performing aseptic procedures including media preparation, antigen inoculation and harvest, ... tissue culture preparation and harvest, filling vaccines, etc.-Assist with performing non- aseptic procedures including handling of live poultry in the process of… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …use, foundational and core skills, systems, unit operations and aseptic processingPrepares and maintains training lab, materials and equipmentConducts Observation, ... is required. Candidate must have experience working within an aseptic manufacturing facility, preferably in training/system applications, quality systems, or… more
- Merck & Co. (Durham, NC)
- …operations, technical services, supply chain, and/or quality operationsExperience with aseptic processing operations such as bulk production, formulation, vial ... filling, and lyophilization, and/or supporting clean utilitiesDemonstrated ability to work in fast-paced, complex environments and escalate appropriatelyFlexibility and ability to manage multiple prioritiesDemonstrates interpersonal, technical aptitude and… more
- Aequor (Pearl River, LA)
- …workspaces and biosafety cabinets. The incumbent should be proficient in aseptic technique, preventive maintenance, and changeovers for area equipment, including ... biosafety cabinets, magnetic mixers, in-process testing equipment (pH / conductivity meters and turbidity meters). Secondary responsibilities will be to aid in the troubleshooting of problems as they arise in downstream and buffer preparation areas. Business… more
- Aequor (Thousand Oaks, CA)
- …and computing data. Ability to maneuver 50&plus pounds General understanding of aseptic techniques, cGMPs, gowning, sampling procedures and safety guidelines Work as ... a team player and/or independently Multi-task and basic problem solving skills Excellent communication skills Time management Proficient computer skills (ie documentation systems, databases and spreadsheets). Bachelor's degree OR Associate's degree and 4 years… more
- Aequor (North Creek, WA)
- …experience in laboratory or manufacturing setting (preferably cell culture) Exceptional aseptic technique and familiarity with common bioreactor and cell culture ... Work experience in a cell culture laboratory or manufacturing setting 2. Aseptic technique 3. Mammalian cell culture Soft Skills: Detail Oriented Communication… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is required, ideally has cGMP cleanroom manufacturing experience under aseptic conditionsProficiency in more than one craftExperience in the Pharmaceuticals ... industry is preferredExperience working in a controlled, cleanroom environment under aseptic conditions is preferredExperience in HVAC and cleanroom maintenance is… more
- Aequor (Swiftwater, MN)
- …to work with minimum supervision Experience in cell culture procedures and associated aseptic techniques is a plus Fluent in both written and spoken English Strong ... experience in Microsoft Excel, Word and Power Point is important more
- Aequor (Athens, GA)
- …skills and attention to detail. Tasks to be completed may include aseptic filling of vials under sterile conditions, vial preparation and sterilization, capping ... of vials under non-sterile conditions, and general support activities related to filling. Operates general manufacturing equipment in strict accordance with SOPs to complete tasks as noted above. Brings deviations in process protocols to supervisors attention.… more
- Merck & Co. (Durham, NC)
- …SCADA, DCSs, MES, Batch Operations (S88/S95), IT, and OEM.Ability to perform aseptic gowning during the execution of job dutiesStrong leadership, interpersonal and ... communication skills (written and oral) are requiredCurrent Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …inventory management and data entry, sample management and data entry, aseptic behavior for cleaning of equipment, and cryopreservation) according to standard ... operating procedures and batch records, while recording production data and information in a clear, concise format.Perform tasks on time in a manner consistent with safety policies, quality systems, and cGMP requirements.Build strong partnerships with… more
- Merck & Co. (Rahway, NJ)
- …communication skills, both verbal and written.Expertise in drug product aseptic processing, equipment, and sterile technique.Experience in leading quality ... investigations and change management.Familiarity with United States and European Union GMP and Safety compliance regulations.Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical ... quality, or cell therapy.GxP Quality System knowledge, including relevant regulations and guidances (eg 21 CFR parts 210, 211, 1271, 600, 601, 610, ICH Q10, EU GDP/GMP, Part 11/Annex 11, PIC/S, MHRA).Strong written and verbal communication, analytical problem… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical ... quality, or cell therapy.Knowledge of cGMP regulations and FDA/EU guidance related to GMP manufacturing of biopharmaceuticals.Experience in supporting cell-based products is a plusStrong knowledge of GxP complianceExperience in cGMP regulatory body… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …of experience in cGMP cleanroom manufacturing experience under aseptic conditionsTechnical knowledge in metrology, calibrations, instrumentation, automation PLCs, ... VFDs and electrical practices generally attained through hands-on experience, cGMP compliance, EHS and regulatory standards (eg EPA, OSHA and DEA)Experience in a growth environment managing the fast pace of change, balancing day to day operational demands with… more
- Twist BioScience (South San Francisco, CA)
- …handling, molecular biology protocols, cell culture, fermentation, purification, aseptic filling, media/buffer prep, etc.) and associated automation/control systems ... (SCADA, DCS, PLC, HMI) from a software integration perspective.Expertise in computer system validation (CSV) and GxP documentation practices, particularly for custom-built systems.Experience with system integration (eg, ERP, LIMS, QMS) using APIs, web… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Knowledge, Skills, and Abilities Knowledge of laboratory practices required (such as aseptic technique, use of pipettes, pH etc.) The ability to understand and ... execute established written instructions is essential Good organization and documentation skills Strong Attention to detail Ability to prioritize tasks Ability to train others Physical Requirements 0-5% overnight travel required. The ability to climb, balance,… more