Technician II

Noven Pharmaceuticals•Miami, FL

About The Position

The Technician II provides technical support to manufacturing, engineering, and other departments to maximize equipment uptime and address technical challenges. When not supporting manufacturing, the technician completes scheduled preventive maintenance work orders through the CMMS system. Under limited supervision, the role also performs and documents moderately complex technical work related to testing, layout, quality control, fabrication, modification, and assembly of mechanical equipment and components. The technician troubleshoots and maintains manufacturing equipment, prepares and inspects tooling for production changeovers, carries out equipment setups and alignment, and supports production operations as needed. The role requires following and contributing to SOPs, work instructions, safety procedures, and GMP standards, as well as documenting equipment changes and test results. The position works with engineers and other technical team members on process development and improvement, and may recommend changes based on findings. The work takes place on a pharmaceutical production and plant floor. The role may require working beyond the standard schedule, including weekends and holidays, with little or no notice.

Requirements

Associate's degree (AA or AS) or equivalent; or trade/technical schooling and 5–9 years of related experience and/or training; or an equivalent combination of education and experience.
Intermediate knowledge of mechanical, hydraulic, pneumatic, and electrical systems.
Strong writing, oral communication, and technical editing skills.
Ability to work independently with minimal supervision within established procedures and provide efficient, effective, and reliable services.
Ability to work with internal and external constituents and make appropriate decisions with minimal intervention.
Knowledge of proper power-tool usage.
Ability to contribute to a team environment.
Excellent organizational skills and strong communication skills.
Ability to use a computer and associated software.
Ability to solve practical problems in situations with limited standardization and use detail-oriented problem-solving skills to help resolve difficult mechanical or electrical issues.
Ability to interpret written, oral, diagram, and schedule-based instructions.
Ability to work additional hours, weekends, and holidays with little or no notice.
Ability to lift and/or move up to 100 pounds.

Nice To Haves

Pharmaceutical industry work experience.
Computer literacy in Microsoft Office.
AutoCAD or SolidWorks skills.

Responsibilities

Complete preventive maintenance requirements and scheduled PMs on manufacturing equipment in a timely manner, meeting work-order due dates.
Provide feedback on preventive maintenance effectiveness and recommend improvements to instructions.
Work with manufacturing to monitor and quickly resolve technical issues with equipment.
Perform or assist with production operations as requested to maintain workflow or prevent downtime.
Perform moderately complex testing, troubleshooting, debugging, installation, and repair of components, subassemblies, and systems to identify root causes and suggest remedies.
Inspect, maintain, and clean production tooling, and prepare tooling for changeovers according to the production schedule.
Execute repeatable setup procedures; maintain and clean manufacturing equipment; and align equipment for each size or product.
Know setup requirements for manufacturing lots, identify and diagnose issues, and develop and implement solutions.
Ensure equipment and tooling are calibrated or inspected before use.
Operate machinery to produce components and products after training.
Read and follow SOPs, work instructions, and protocols, and contribute to their development and improvement.
Document equipment changes and work accurately in logbooks, work orders, data entry systems, data sheets, and other required records.
Verify that GMP and safety standards are maintained, address or follow up on deficiencies, and follow lockout/tagout procedures.
Maintain a clean, orderly, and organized work environment; practice safe work habits; complete required safety and environmental hazard training; and interpret MSDS sheets.
Work with engineers and other technical team members during process development, provide feedback and improvement recommendations, and record test procedures, results, data, and recommendations for changes.
Update SOPs and preventive maintenance instructions related to the role.
Use metrology equipment such as indicators, comparators, microscopes, and micrometers.
Communicate effectively across personnel levels, participate in team activities and shift transitions, and inform appropriate personnel of improvement ideas, problems, or concerns.
Work additional hours or beyond the standard schedule, including weekends and holidays, with little or no notice.
Maintain Noven's compliance training.