Manufacturing Technician III

Nova Pneuma Inc

Fremont, CA

JOB DETAILS
SALARY
$32–$38 Per Hour
SKILLS
Biology, Calibration, Cleanroom, Clinical Trial, Communication Skills, Computer Skills, Cross-Functional, Current Good Manufacturing Practice (cGMP), Detail Oriented, Documentation, Drug Compounds, Drug Development, English Language, Facilities and Maintenance, GMP (Good Manufacturing Practices), High School Diploma, Identify Issues, Interpersonal Skills, Leadership, Lift/Move 35 Pounds, Lift/Move 40 Pounds, Manufacturing, Manufacturing Operations, Medical Equipment, Medical Products, Microsoft Excel, Microsoft Word, Multitasking, OSHA, Organizational Skills, People Management, Physical Demands, Presentation/Verbal Skills, Procedure Development, Process Improvement, Process Validation, Product Testing, Regulations, Research & Development (R&D), Safety Training, Safety/Work Safety, Standard Operating Procedures (SOP), Testing, United States Drug Enforcement Agency (DEA), Willing to Travel, Workplace Issues, Writing Skills
LOCATION
Fremont, CA
POSTED
30+ days ago

Welcome to Nova Pneuma - a company built on innovation and a shared commitment to creating meaningful medicines for patients in need. Innovation requires bold thinking and the courage to persevere despite setbacks, criticism, and uncertainty. We believe in providing our employees with a purpose centered on innovation, along with the freedom to take thoughtful risks in pursuit of creative ambition. By fostering a culture of curiosity, collaboration, and resilience, we create the foundation for both scientific breakthroughs and long-term value for our company.

 

Job Summary

The Manufacturing Technician III performs functions associated with all GMP manufacturing operations, including working with engineers in set-up and calibration tasks, production documentation, as well as performing in-process and quality testing related to product parts, components, subassemblies, and final assemblies.

 

Responsibilities

• Manufacture supplies for development, clinical studies, and commercial product • Independently set-up, operate, and troubleshoot production equipment • Independently perform complex tasks to support R&D and development activities • Interact with R&D and Technical Services personnel to provide assistance in the optimization of processes • Set-up, operate, and troubleshoot a broad range of equipment (bench-top, medium, large scale) • Execute experimental, clinical, and process qualification and validation production activities • Provide feedback to project personnel on issues related to the process, testing, and operations • Update and revise SOP's and documentation and provide on-the-job training to other Technicians • Ensure a safe work environment is maintained at all times and follow up with Safety Incident Report investigations • Interact with Maintenance and Facilities to ensure equipment and facilities are maintained in good working order • Ensure that all pertinent issues are communicated between shifts (as required) • Participate as and interact with Manufacturing Team members seamlessly to attain production goals

 

Skills Required

• Able to work independently in a dynamic, multi-tasking, and cross-functional environment • Strong oral and written communication skills in English • Demonstrates good judgment within defined procedures and practices to determine appropriate action • Strong organizational skills with keen attention to details • Self-starter who takes initiative and is able to work with minimal supervision • Good understanding of cGMP, DEA, and OSHA regulations • Good mechanical aptitude and experience in handling drug compounds and organic solvents • Must perform duties in accordance with current Good Manufacturing Practices (cGMPs) as detailed by the U.S. and European Regulatory Agencies • Must work in a clean room environment and conform to specific gowning and safety requirements • Willing and able to work flexible hours and capable of working independently on several tasks simultaneously • Good interpersonal skills and tact needed to interact with personnel from a wide range of disciplines • Some leadership and/or supervisory skills preferred • Good computer skills, including but not limited to MS Word and Excel

 

Education Required

A high school diploma or equivalent 4+ years experience in the biopharmaceutical or medical device industry AA or AS in Life Sciences or Engineering discipline preferred

 

Physical Requirements

Prolonged periods of sitting at a desk and working on a computer Potentially prolonged periods standing Must be able to lift up to 35-40 pounds at times Must be able to travel

 

Compensation

$32-38/h commensurate with experience

About the Company

N

Nova Pneuma Inc