|
|
| ASEPTIC
FILL TECHNICIAN
Assists in the operation and maintenance of production systems. Other responsibilities include setting up, changing-over and operating labeling and packaging equipment. Requires a BS or equivalent in a scientific discipline for senior-level positions or an AS or certificate in Biomanufacturing for entry-level positions and a minimum of 0-2 years work experience in an aseptic fill manufacturing environment. Knowledge of manufacturing procedures and federal regulations pertaining to manufacturing processes is preferred. CHEMISTRY QC TECHNICIAN Performs a wide variety of inspections, checks, tests and sampling procedures for the manufacturing process according to Standard Operating Procedures. Performs in-process inspection and documents results. Monitors critical equipment and instrumentation. Write and updates inspection procedures and checklists as necessary. Requires a high school diploma, Biotech Certificate, AS degree or equivalent with a scientific background and a minimum of 0-5 years in quality control systems with knowledge of good manufacturing practices. ENVIRONMENTAL HEALTH & SAFETY TECHNICIAN Responsible for water and air sampling and monitoring, processing permits, calibration and maintenance of scientific monitoring, data collection and routing analysis. Installs and services recording instruments, maintains physical stations where data is collected, inspects stations records to ensure quality assurance and preventative maintenance procedures are conducted properly. May conduct special studies such as toxic water monitoring, biological monitoring , air/water pollutant investigations and recommend corrective actions. Records and maintains periodic data logs and information files. Typically works from drawings, specification, diagrams, schematics and specific verbal and written instructions. Requires a high school diploma or equivalent with some specialized or technical training in environmental sciences, chemistry, math hydrology, ecology, toxicology or related field. A 2 or 3 year community college program in environmental technology is preferred. Working knowledge in sampling, data collection and analysis, pollution complaint investigators, instrument calibration, environmental law or experience in assessing environmental conditions is desirable. FACILITIES TECHNICIAN Performs daily monitoring, repair, and preventative maintenance activities on critical systems and facility equipment. Troubleshoots, installs and modernizes new and existing systems, including refrigeration equipment, water systems, HVAC systems, and electrical systems. Documents repairs, adjustments, and replacement of equipment and/or components per GMP standards. May also provide input and corrections to SOPs and assist in engineering in the evaluation of new equipment or technology. Requires an AA/AS or Certificate of Completion as a 2-year technical school in mechanical/electrical field or a high school diploma or equivalent with 5+ years of experience in GMP maintenance. Knowledge of major trades, such as carpentry, electrical, plumbing and HVAC/refrigeration including the ability to interpret blueprints, technical manuals and specification are required. Experience in pharmaceutical or bio pharmaceutical environment is required. MANUFACTURING INSTRUMENTATION/ CALIBRATION TECHNICIAN Maintains, tests, troubleshoots and repairs a variety of circuits, components, analytical equipment and instrumentation. Calibrates instrumentation and performs validation studies. Specific and requests purchase of components, Analyzes results and may develop test specification and electrical schematics. Performs continuous monitoring of equipment status, condition and location. Prepares required documentation for the recording and notification of events and changes related to equipment such as calibration certificates, deviations, out of tolerances and installation reports. Requires and AS or equivalent in electronics technology or equivalent technical training related to mechanics or instrumentation and a minimum of 2-4 years experience with instrumentation, problem diagnosis and repair. Knowledge and understanding of measurement parameters and experience working in a GMP environment is preferred. |
MANUFACTURING
TECHNICIAN
Responsible for assisting manufacturing in specific product-related operations in cell culture/fermentation. Operates and maintains production equipment as it relates to cell culture/fermentation. May also assist manufacturing in production-scale protein purification and manufacturing of final products. Weighs, measures and checks raw materials to assure proper ingredients and quantities. Prepares media and buffer components. Maintains records to comply with regulatory requirements and assists with in-process testing. Requires a high school diploma or equivalent, certificate in Biomanufacturing., AS degree or equivalent experience plus a minimum of 0-2 years related work experience in a manufacturing environment. METROLOGIST Develops and evaluates calibration systems that measure characteristics of objects, substances, or phenomena, such as length, mass, time, temperature, electric current, luminous intensity, and derived units of physical or chemical measure, Identifies magnitude of error sources contributing to uncertainty of results to determine reliability of measurement process in quantitative terms. Redesigns or adjusts measurement capability to minimize errors. Develops calibration methods and techniques based on principles of measurement science, technical analysis of measurement problems and accuracy and precision requirements. Directs engineering, quality, and laboratory personnel in design, manufacture, evaluation, and calibration of measurement standards, instruments, and test systems to ensure selection of approved instrumentation. Advises others on methods of resolving measurement problems and exchanges information with other metrology personnel through participation in government and industrial standardization committees and professional societies. MICROBIOLOGY QC MICROBIOLOGIST Performs routine microbiological testing of raw materials, in-process samples and finished formulations according to SOPs. Conducts routine environmental monitoring of GMPs, manufacturing areas, equipment and processes according to established procedures. Calibrates and maintains microbiology laboratory equipment. Compiles and analyzes data for documentation of test results and prepares related reports. Revises and updates standard operating procedures as necessary. Requires a BS or equivalent in microbiology and 0-5 years work experience. PROCESS DEVELOPMENT ASSOCIATE Responsible for evaluating, improving and scaling-up manufacturing processes in order to improve product yield and reduce overall costs of production. Executes small-to-medium scale production work, which may involve cell culture, fermentation, purification and/or chromatography. Additionally, assists with maintenance of production equipment. May research and implement new methods and technologies to enhance operations and may assist in validation of production processes. Requires a BS/MS or equivalent and 0-5 years of experience in the development and optimization of manufacturing processes. QA DOCUMENTATION COORDINATOR Responsible for providing clerical and administrative support related to documentation system requirements/maintenance. Audits all documentation manuals to assure they are accurate and up-to-date, and available to appropriate personnel. Maintains filing of all master documents and assists in microfilming and archiving activities. Requires a high school diploma, Biotech Certificate, AS or equivalent and a minimum of 2-3 years experience, preferably in documentation or quality control/assurance. VALIDATION SPECIALIST Responsible for developing and recommending validation strategies and designing studies for the purpose of providing documented evidence that a system, equipment, method, or process has been validated. Conducts and processes qualifications programs, writes detailed protocols and reports to document the validation of systems/equipment and provides validation support for facility and utility expansion, compliance upgrades, etc. Develops and implements solutions to validation issues. Requires a BS or equivalent in a scientific, engineering or other related technical field with a minimum of 3 years experience in a regulated industry. Knowledge of current industry practices and GMP requirements related to validation tasks is required,. |
