Technician, Manufacturing

Technician, Manufacturing

Integrated 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.

Job Description

Scope of responsibility:

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.

Purpose of the Position

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 Job Functions

• Troubleshooting equipment and process failures
• Recognize common equipment failures and process anomalies
• Assist 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 guidelines
• Emphasize importance of quality cGMP compliant documentation to coworkers
• Provide on-the-job training, emphasizing cGMP compliance
• Provide a positive reinforcing, open learning atmosphere
• Tailor training style to meet individual needs
• Set a good example in observance of cGMP and Quality
• Follow up on instructions/suggestions to ensure compliance
• Demonstrate leadership by example and participation
• Compliance with safety guidelines
• Use safety eyewear while inside a manufacturing area
• Know appropriate emergency response procedures
• Know locations of first aid kits, safety showers, and spill kits
• Know evacuation route and assembly area to be used in case of fire or earthquake
• Know the location of MSDS binders and understand how the guidelines pertain to operations
• Follow good chemical safety practices
• Comply with all cGMP Documentation and procedures
• Record information accurately
• Make corrections in a timely manner
• Check all necessary calculations
• Review pre-recorded data for accuracy and completion
• Ensure all entries are neat and legible
• Understand operator and verifier responsibilities
• Review labels and equipment calibrations prior to use
• Perform preliminary review of completed documentation
• Keep logbooks updated and accurate
• Comply with cGMP Practices and Regulations
• Generate clear and concise labels for all in-process equipment and materials
• Understand, observe, and practice proper gowning
• Understand flow of materials and personnel in the manufacturing areas
• Maintain clean and well-stocked labs
• Compliance with Policies and Regulations
• Compliance with 21 CFR - Parts 210 and 211

Qualifications

Education:

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 chemistry
• Knowledge of relevant unit operations.
• Sterile cell culture
• Disposable bioreactors (25 to 100L, Wave, SUB) / viral vector manufacturing
• Disposable clarification / filtration (pharmaceutical unit operations)
• Ultrafiltration / Diafiltration
• GE Process Skid operation / column chromatography / column packing
• Bulk Drug Formulation and dilution
• Sterile Fill / Finish
• Working knowledge of desktop computers and technical equipment