Manufacturing Technician II Albumin Nights応募後で応募 求人ID R0036824 掲載日 06/15/2021 Location:Social Circle, Georgia
The role is responsible for executing all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. In addition to making routine revisions to documents, he/she may rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. He/She has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills.
- Prepare media and buffer solutions.
- Operate Clean-in-Place (CIP) and Steam-in-Place systems.
- Assemble and operate filtration systems.
- Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc.)
- Monitor and record critical process parameters.
- Complete all relevant paperwork following GDP/GMP guidelines.
- Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion.
- Perform sampling using aseptic techniques. Participate on Continuous Improvement Teams.
- Train and mentor other team members.
- Write, revise and review pertinent documentation as appropriate.
- Troubleshoot process problems and respond to process alarms.
- Assist with process/equipment validation and data analysis.
- Work with other groups such as maintenance/metrology to ensure preventat ive maintenance is done.
- Initiate and/or coordinate other process improvement projects.
- May perform other duties as assigned.
- Responsible to execute material transfers that include non-hazardous, hazardous and flammable chemicals to support manufacturing schedule adherence.
- Maintain a visual replenishment program of materials using lean manufacturing processes/tools.
- Maintain records of materials in inventory and on order.
- Compile inventory records as needed.
- Reconcile discrepancies in inventories.
- Compile information on receipt and transfer of materials.
- Resolve questions and problems and refers only most complex issues to higher levels.
- Contribute to a culture of safety first in compliance with Environmental, Health, and Safety (EHS). Understand and follow Job Hazard Analysis (JHA) packets.
Education and Experience Requirements:
- Include educational requirements or equivalency, required years and type(s) or experience, and
- necessary licenses or certificates. Specify which are required and which are preferred. For UK,
- please do not use years of experience due to UK Legislation
- Typically requires high school diploma or GED plus 2+ years of experience or associates’ degree or higher and 1+ years of related work experience.
Key Skills, Abilities, and Competencies
- Knowledge of cGMP manufacturing.
- Knowledge of basic laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, incubators, analytical equipment and CIP/SIP systems.
- Must be able to apply quantitative analysis to analyze process performance.
- Incumbent must be proficient in a variety of mathematical disciplines and be able to work with both the metric and USA standards of measurement.
- Must be able to read and follow detailed written instructions and have good verbal/written communication skills. Good procedural writing skills.
- Knowledge of basic chemical and biological safety procedures.
- Good computer skills, knowledge of Microsoft Word and Excel.
- Very good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Must have and display the following personal attributes: Integrity, trust, work ethic, sound judgment, intellectual honesty, and conviction.
- Must have experience with inventory management.
- Experience in handling pallet-jacks, pallet trucks, and forklifts are a plus.
Other Job Requirements
- Must be able to carry up to 25 lbs., lift up to 50 lbs., and push/pull > 100 lbs. (with the assistance of material handling equipment).
- Must be able to stand for extended periods of time over an entire 8 or 12-hour shift.
- Must be able to climb ladders and stairs while wearing special gowning.
- May require bending, twisting, reaching overhead, and/or squatting motions to perform certain tasks.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Will work in a cold, wet environment.
- May be working in a loud area that requires hearing protection and other protective equipment to be worn.
- Will work around chemicals such as alcohol that may require respiratory protection.
- Will handle non-hazardous, hazardous and flammable materials/chemicals.
- Must be able to work multiple shifts, including weekends. Must be able to work overtime as required.
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
- May require immunization before performing work within the manufacturing area.
This posting excludes CO applicants.