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Manufacturing Technician II
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 troubleshooting 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.
Job Function and Description
·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 preventative maintenance is done.
·Initiate and/or coordinate other process improvement projects.
·May perform other duties as assigned.
·Support change control process. Initiate and close change controls records in Trackwise, as needed.
·Support corrective and preventive actions (CAPA) implementation and data analysis, as needed.
·Ensure manufacturing log books are reviewed and corrected in a timely manner.
·Support JDE work order closure, as needed.
·Support material onboarding process.
·Support manufacturing Return to Service / Disruption to Classified Areas (DCA) process.
·Contribute toward routing and submitting to Document Control SOPs and Job aids, associated to manufacturing processes, as needed.
·Communication with support groups for key activities taking place on the floor.
·Understand supplier/customer process streams and interdependencies.
·Complete written documentation of work performed following GDP/GMP guidelines.
·Escalate issues or decision effectively.
·Represent the department in cross functional teams as necessary.
·Support continuous improvement activities.
·Support and participate in Quality and EHS gemba walks.
·Contribute to a culture of safety first in compliance with Environmental, Health, and Safety (EHS).
Education and Experience Requirements
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 possess the ability to work independently and effectively with peers, and display strong interpersonal and organizational skills.
·Must have customer service and leadership attitude to take ownership of any problem.
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.