Manufacturing Tech I

Manufacturing Tech I

Location: San Diego, CA 92121

Duration: 12 months

Schedule: 1st shift

PR: XXXXXXXXXXX/hr

Summary of Position: Under general supervision, the scope of this position is responsible for a variety of assembly and non-assembly functions in support of manufacturing goals.

Essential Functions:

• Responsible for completing set-up operations for one or multiple of the following: assembly, packaging, and prep operations in compliance with approved documentation and QSR.
• Responsible for the completion and accuracy of documentation associated with the manufacturing processes.
• Responsible for cleaning, performing, and documenting routine equipment maintenance and minor repair.
• Assists in Lean Initiatives, such as 5S and Zone assignments.
• Responsible for record keeping.
• Responsible for supporting new equipment installation and validation.
• Carries out duties in compliance with established business policies.
• Perform other duties & projects as assigned.

Interactions:

• Collaborates with peers, mechanics, engineers, and management to resolve technical problems.
• Expresses ideas and opinions objectively to peers, mechanics, engineers, and management; handles conflicts maturely.
• May orient new employees to work area.
• Possesses the ability to effectively organize the efforts of small groups of people (5-8).
• Capable of assessing team performance and making recommendations for improvement.
• Train contract employees/peers as required.
• Active involvement in group meetings – departmental and cross-functional.

Work Environment: The work environment characteristics are representative of a manufacturing environment and may include handling of viral and bacterial hazards as well as infectious or potentially infectious bodily fluids, tissues, and samples. Flexible work hours to meet project deadlines.

Physical Demands: Position requires ability to lift up to 50 lbs. on a regular basis. May be required to perform repetitive manufacturing processes (e.g., manual lamination, manual cassette assembly, pouch inspection, etc.) up to 90% of workday. Walking, standing, and/or sitting for long periods of time (up to 75% of the day) are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Personal protective equipment is required as posted.

Education and Experience:

• High school diploma or equivalent required.
• One to two years of related experience required.

Skills and Knowledge:

• Knowledgeable of federal and other regulations.
• Computer operated experience required.
• Knowledge of MS Office and manufacturing systems required.
• Experience with working with semi-automated equipment required.
• Basic knowledge of GMP and Documentation Practices required.
• Demonstrates commitment to the development, implementation, and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
• Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing, and testing activities.