Lead Manufacturing Technician

Nova Pneuma; Colorado; On-site; USD 44,083 - 75,768; Full time

Job summary

Nova Pneuma is seeking a skilled technician to lead manufacturing processes for R&D projects in Fremont, CA. The ideal candidate will manage a team, tackle complex tasks, and ensure compliance with production standards.

The role demands at least 6 years of experience in the biopharmaceutical or medical device industry, with a focus on safety and efficiency in practices. Compensation is competitive at $32-55/hour based on experience.

Qualifications

• 6+ years of experience in the biopharmaceutical or medical device industry.
• High school diploma or equivalent experience.
• AA or AS in a Life Sciences or Engineering discipline preferred.

Responsibilities

• Lead team of Technicians manufacturing supplies.
• Independently perform complex tasks for R&D activities.
• Interact with R&D to optimize processes.
• Set-up, operate, troubleshoot equipment for manufacturing.
• Lead process qualification and validation activities.
• Generate and revise SOPs and Production Records.

Skills

Development of concepts and techniques

Independent action and initiative

Team leadership

Education

High school diploma or equivalent

6+ years in biopharmaceutical or medical device

AA or AS in Life Sciences or Engineering

Job description

6550 Dumbarton Cir
Fremont, CA 94555, USA

Description

Responsibilities

• Lead team of Technicians manufacturing of supplies for development and clinical studies
• Independently perform a variety of highly complex tasks to support R&D and development activities
• Interact with R&D and Technical Services personnel to provide input and expertise and to assist in the optimization processes
• Independently set-up, operate, troubleshoot and dismantle a broad range of equipment (bench-top, medium, large scale used for the manufacturing of Nova Pneuma Inc products
• Lead and coordinate the execution of experimental, clinical and process qualification and validation activities
• Lead select manufacturing processes and initiate investigations when deviations occur
• Assume the responsibilities of Supervisor when absent
• Generate and revise SOPs, Production Records and IOQ documents
• Provide leadership and direction to Technicians when needed
• Provide on-the-job and SOP training including facilitating group training
• Ensure a safe work environment is maintained and initiate and investigate Safety Incident Reports when they occur
• 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)

Skills required

• As a highly skilled specialist, contributes to the development of concepts and techniques.
• Completes complex tasks in creative and effective ways.
• Consistently works on complex assignments requiring independent action and a high degree of initiative to resolve issues. Makes recommendations for new procedures.
• Acts independently to determine methods and procedures on new assignments.
• Often acts as a facilitator and team leader.

Education and experience

• A high school diploma or equivalent experience
• 6+ years experience in the biopharmaceutical or medical device industry
• AA or AS in a 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 15 pounds at times
• Must be able to travel

Compensation:

• $ 32-55/h commensurate with experience

Equal Opportunity Employer
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