Technician II at Noven Pharmaceuticals, Inc - Miami, FL in Miami, Florida

Job Description:

Provide technical support to manufacturing, engineering and other departments / teams by ensuring maximum equipment uptime, and addressing technical challenges. When not supporting manufacturing, technician shall perform scheduled PMs in timely manner as required by the CMMS system for work orders. Lastly, under limited supervision, performs and documents moderately complex technical functions relating to test, layout, quality control, fabrication, modification and assembly of mechanical equipment and/or components. 

• Ensures maximum uptime of manufacturing equipment by completing preventive maintenance requirements.


• Provide continuous feedback on preventive maintenance effectivity and improvements to the instructions based on usage and experience.


• Executes scheduled Preventive Maintenance on manufacturing equipment in timely manner to always meet due dates.


• Works with manufacturing to monitor and quickly resolve technical issues on manufacturing equipment.


• Perform or assist with any production operation to maintain work flow or prevent downtime per production requests.


• With minimal supervision, performs moderately complex testing, troubleshooting, debugging, installation and repair of components, sub-assemblies and systems to isolate root cause and suggest remedies.


• Performs in-house inspection, maintenance and cleaning of all tooling required for changeovers within all areas of production.


• Prepares and provides manufacturing with tooling required for changeovers per production schedule.


• Execute repeatable setup procedures, maintains and cleans semi-complex manufacturing equipment and performs equipment alignment for each size/product. Must know all setup requirements for manufacturing lots.


• Must be able to identify issues encountered during day to day tasks, diagnose its cause and develop and implement a solution.


• Ensures equipment/tooling is properly calibrated / inspected before using.


• With training provided, demonstrates the ability to operate machinery to produce components and products.


• Reads and follows SOPs, work instructions and protocols.  Contributes to the development and improvement of these documents.


• Accurately documents changes to any equipment used in the development, testing or manufacture of products as per respective SOPs, i.e. in logbooks, work orders, data entry, data sheets, etc.


• Verify GMPs and safety standards are maintained at all times and take action and/or follow-up when deficiencies are noted.


• Follow lockout/tag out procedures.


• Maintains a clean, orderly and organized work environment.  Practices safe work habits and completes required safety and environmental hazard training.  Able to interpret MSDS sheets.


• May work closely with engineers or other technical team members during process development using limited documentation and only general support.  May offer feedback and improvement recommendations based upon findings.


• With necessary guidance, records test procedures and results, numerical and graphical data, and recommendations for changes in product or test method.


• Performs updates to the SOPs related to role, as well as to PM instructions.


• Able to use metrology equipment (indicators, comparators, microscopes, micrometers, etc.).


• Ability to multitask and assess priorities.


• Able to read and understand engineering drawings. AutoCAD or SolidWorks skills are desired.


• Communicates effectively with personnel at all levels and effectively participate in a team environment, particularly for effective shift transitions.


• Inform appropriate personnel of improvement ideas, problems or concerns.


• Must be able to work additional hours, or beyond standard schedule, including holidays and weekends with little or no notice.


• Maintains Noven’s compliance training.   

Competencies:

• Must have intermediate knowledge of mechanical, hydraulic, pneumatic and electrical systems.


• Strong writing and oral skill as well as technical editing skills.


• Ability to work independently with minimal supervision within established procedures, providing efficient, effective and reliable services.


• Ability to work with internal and external constituents


• Able to make appropriate decisions with minimal intervention


• Knowledge of proper power tools usage.


• Ability to contribute to a team environment.


• Excellent organizational skills.


• Strong communication skills


• Computer literacy in Microsoft Office is preferred.

Education / Experience:

Associate’s Degree (AA or AS) or equivalent; or trade/technical schooling and 5-9 years of related experience and/or training; or the equivalent combination of education and experience.  Pharmaceutical industry work experience is a plus. Ability to use computer and associated software.

Judgment / Decision Making:

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.  Use detail-oriented problem solving skills to assist in solving difficult mechanical or electrical issues. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form   

Work Environment:

Production/plant floor – pharmaceutical products

Physical Demands:         

The employee will be occasionally required to climb or balance; stoop, kneel, crouch, or crawl; and smell.  The employee must be able to lift and/or move up to 100 pounds.