Manufacturing Tech I

Who we are:

Charter Medical, LLC is a life sciences company that is committed to designing, developing, and manufacturing quality products to support cell and gene therapy, bioprocessing, and blood management.

About the role:

The Manufacturing Technician’s primary role is to work as a member of the production Line Team. In addition, this role provides mechanical troubleshooting, and performs changeovers, and repairs as needed. There are three (3) levels within this position.

3rd Shift: Sunday - Thursday 11:00 pm-7:00 am

What you will do:

• Supports production needs as required as an operator
• • Manually assembles and packages components of a medical device. Labels and packages per specifications.
  • Performs in-process inspection and testing of material to ensure it meets criteria, elevating to management and documenting/reporting defects into the production records. Requires measuring and simple mathematical calculations to ensure product meets specification requirements.
  • Participates in cross training and works at various stations to meet business needs.
  • Operates and runs equipment producing products used in the medical device industry.
  • Maintains clean machinery, parts and surrounding area.
  • Completes all associated paperwork & ERP tasks, coordinating with Line Leads to maintain quality requirements.
  • Operates equipment following safety guidelines.
  • Reports any nonconformance
• Provides mechanical troubleshooting across manufacturing floor such as tooling alignment, Teflon changes, mandrel changes and repairs on equipment as needed
• Tests and documents result of completed production processes
• Performs machine changeovers per specification/verifications which includes proper documentation of machine settings as well proper tooling to support production

Other Duties

• Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOP’s, Work Instructions) to successfully accomplish job requirements.
• Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, eye protection as required.
• Follows gowning procedures in designated areas.
• Follows established safety requirements and adheres to the Health Safety and Environment Management System.
• Assists in the training of new employees
• Performs other job-related responsibilities as assigned.

Who you are:

• High School diploma or equivalent.
• 3 to 5 years’ experience in related field, or an equivalent combination of education and experience.
• Must be capable of completing assembly and test records for regulatory requirements.
• Ability to read schematics and technical drawings.
• Ability to perform complex test operations and operate and maintain test equipment.
• Ability to understand and follow the requirements of applicable work instructions and/or internal specifications.
• Ability to effectively communicate with coworkers and management. Business communication is conducted in English.
• Ability to comprehend and follow SOP’s, WI’s, policies, and procedures such a safety, quality, and HR that are written in English.
• Possess basic mathematical skills to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
• Basic understanding of GMP and working within FDA regulated industries preferred.
• Basic computer skills including ability to use MS Outlook and automated manufacturing and quality systems.
• Familiarity with an ERP system and Quality Management System (eQMS) preferred.
• Technical education preferred.
• Prior experience as an Engineering and/or Research Technician in a Manufacturing Environment (preferred).
• Must be able to work extended hours when required.
• 20/20 vision (with corrective eyeglasses) and ability to pass a color perception test.

Perks / Benefits:

• Generous Paid Time Off
• Paid Breaks
• Quarterly Bonuses
• 401k with excellent company match
• Health Insurance with multiple plans to choose form
• Paid Short Term and Long Term Disability