Technician, Manufacturing

Technician, ManufacturingIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.The Tech III position will be a primary entry point for GMP Manufacturing of biologics at the Carlsbad site and a promotion from Tech I/Tech II. Differentiation on Tech level will be based on experience levels in GMP Manufacturing at both the Carlsbad site and at external locations. These positions do not have supervisory responsibility. Employees will support projects in conjunction with other GMP Manufacturing personnel (Leads, Supervisors, and Managers). Employees will have no specific decision-making authority as they are asked to follow GMP batch records. Employees are expected to prepare suites for manufacturing, to document deviations, and to operate in a safe manner for the employee, others in the GMP Manufacturing suites, and for the Product being manufactured.The Manufacturing Biologists (Tech III) in the Operations department are responsible for performing mammalian cell culture, buffer and medium preparation, membrane clarification, TFF (UFDF) concentration and buffer exchange, column purification, terminal filtration, Fill and Finish, stocking supplies and raw materials, and cleaning in process equipment. Responsible for setting up and operating Bioreactors (Applikon, Wave, SUB), and large scale Purification equipment (BioProcess skid). Manufacturing Biologists are responsible for drafting Batch Production Records and Standard Operating Procedures. Provide supervision for GMP operations as necessary. Manufacturing Biologists will be progressively developing competency in cGMP manufacturing of biopharmaceuticals and will be trained towards proficiency in all unit operations including; Project Leadership and Project Planning. Manufacturing Biologists are to assist in the training and development of Manufacturing Technicians.Essential Functions:Troubleshooting equipment and process failuresRecognize common equipment failures and process anomaliesAssist in Deviation Investigations, Corrective Action, Preventative Action, and Document Training.Author Document Change Requests for Batch Production Records, Standard Operation Procedures, Item Specifications, and Qualifications.Leadership:Reinforce cGMP documentation guidelinesEmphasize importance of quality cGMP compliant documentation to coworkersProvide on-the-job training, emphasizing cGMP complianceProvide a positive reinforcing, open learning atmosphereTailor training style to meet individual needsSet a good example in observance of cGMP and QualityFollow up on instructions/suggestions to ensure complianceDemonstrate leadership by example and participationCompliance with safety guidelinesUse safety eyewear while inside a manufacturing areaKnow appropriate emergency response proceduresKnow locations of first aid kits, safety showers, and spill kitsKnow evacuation route and assembly area to be used in case of fire or earthquakeKnow the location of MSDS binders and understand how the guidelines pertain to operationsFollow good chemical safety practicesComply with all cGMP Documentation and proceduresRecord information accuratelyMake corrections in a timely mannerCheck all necessary calculationsReview pre-recorded data for accuracy and completionEnsure all entries are neat and legibleUnderstand operator and verifier responsibilitiesReview labels and equipment calibrations prior to usePerform preliminary review of completed documentationKeep logbooks updated and accurateComply with cGMP Practices and RegulationsGenerate clear and concise labels for all in-process equipment and materialsUnderstand, observe, and practice proper gowningUnderstand flow of materials and personnel in the manufacturing areasMaintain clean and well-stocked labsCompliance with Policies and RegulationsCompliance with 21 CFR - Parts 210 and 211QualificationsEducation:Bachelor of Science degree or equivalent work experience.Experience:Minimum of 3 years of directly related experience.Essential and Critical Skills:Knowledge of biology and chemistryKnowledge of relevant unit operations.Sterile cell cultureDisposable bioreactors (25 to 100L, Wave, SUB) / viral vector manufacturingDisposable clarification / filtration (pharmaceutical unit operations)Ultrafiltration / DiafiltrationGE Process Skid operation / column chromatography / column packingBulk Drug Formulation and dilutionSterile Fill / FinishWorking knowledge of desktop computers and technical equipment