Manufacturing Technician I (3rd Shift)

The Position

To produce cartridges, formulation reagents, and other tasks required within the manufacturing environment(s). To operate manufacturing and assembly equipment necessary for production within a clean room environment. To assemble and package various components used in making cartridge and kit assemblies. To follow, and review device manufacturing instructions, records, and work orders. To collect process data used to perform routine analysis for manager review.

ESSENTIAL DUTIES & RESPONSIBILITIES

• Follow cGMP and ISO standards or guidelines as they apply to manufacturing

• Assemble cartridges and reagent kit components

• Follow manufacturing SOPs

• Organize and maintain floor area and supplies used during work performed

• Work independently and as a part of an assembly line team

• Maintain a safe work environment with respect to chemicals and equipment

• Resolve line issues and suggest improvements

• Operate all manufacturing line equipment.

• Adhere to manufacturing schedule and complete manufacturing work orders in a timely manner

• Review completed device manufacturing records and work orders, identify and correct errors, and submit finished documentation for quality release

• Serve as a role model for cGMP manufacturing

• Assist with special projects as requested and perform additional duties as assigned

POSITION REQUIREMENTS

Minimum Requirements:

• High School diploma or equivalent, with a minimum of 1 year of experience in a regulated manufacturing environment

Preferred requirements and skills 

Skills – Technical

• Strong experience with high vacuum chambers and assembly automation equipment 

• Experience in working with printed circuit board inspection, assembly and packaging 

• Experience in working in a clean room environment under cGMP and ISO/FDA standard

• Experience in manufacturing and assembling high quality medical devices is strongly preferred

• Ability to handle delicate materials and do precision manual alignments during manufacturing

• Ability to accurately and thoroughly document work on printed documents and computer databases

• Ability to work according to assigned manufacturing schedule, ranging from an early morning to late afternoon shifts

• Ability to be cross trained on all manufacturing processes with minimal training

• Provide recommendations for floor improvements

 

Skills – General

• Strong influencing and interpersonal skills and the ability to work well with others in a proactive, positive and constructive manner

• Strong quality-orientation with attention to detail and a desire to deliver service excellence is essential

• Must be a hands-on, self-directed, organized and a conscientious individual

• Complete work in a timely, accurate and thorough manner and is conscientious about assignments

• Must be able to think and work both tactically and strategically to provide operational needs to GenMark’s business

• Ability to read, write and analyze complex documents

• Ability to respond effectively to sensitive inquiries, customer inquiries or complaints as well as communicate effectively both orally and in writing with management, peers and individuals

• Ability to work effectively, exhibit a professional manner and establish constructive working relationships

• Proficient with Microsoft Office applications

• Strong problem-solving, judgment and decision-making skills

WORK ENVIRONMENT

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate.  This position may involve a combination of office and biotechnology laboratory environments.   The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear.  The employee is frequently required to stand and walk.  The employee may sometimes be required to lift and/or move up to 35 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

No relocation benefits available for this posting.The expected salary range for this position based on the primary location of California is $32,740-$60,100. Actual pay will be determined based on experience, qualifications, geographic location, and other