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Sr Mfg Process Technician I (2nd Shift)

Amgen
over 2022 years ago
Remote friendly (New Albany, OH)
United States
Operations

Role Summary

Sr Mfg Process Technician I (2nd Shift) operates automated packaging equipment and assists in troubleshooting to maintain safety, quality, and efficiency in a fast-paced manufacturing environment. The role involves cross-training across multiple equipment types including automated lines, assembly, labeling, printing, and robotic automation, and collaborating with cross-functional teams to drive improvements while following GMP.

Responsibilities

  • Under limited supervision, perform equipment setup, operation, and troubleshooting to meet standards for safety, quality and efficiency.
  • Maintain machine uptime, clear faults and stoppages on automated equipment.
  • Perform basic, routine manufacturing process operations such as dispensing of raw materials, material reconciliation, line clearance, basic analytics, and record transactions.
  • Assist in the review of documentation for assigned areas (procedures, job plans, logs, area audits and batch records).
  • Assist as training resource on manufacturing tasks and equipment use.
  • Use human machine interfaces (HMIs) to identify alarms and correct line stoppages.
  • Ensure components and products are available for a continuous operation.
  • Carries out equipment inspections and generates emergency, corrective, or preventative work orders as needed in the Maximo system.
  • Troubleshoot and identify potential solutions for mechanical errors, safety issues or general operating inefficiencies within the production processes.
  • Partner with cross-functional teams to help drive improvement opportunities.
  • Able to use computer systems to support material inventory system (SAP transactions) and electronic batch records.
  • Oversight of equipment/process validation protocols independently.
  • Safely follow standardized operating procedures including material handling, record keeping, assembly and packaging. Must follow Good Manufacturing Practices (GMPs).
  • Reports to Team Leader or Production Supervisor of any discrepancies to ensure quality standards and safety of operations are always maintained.
  • Train fellow staff on the manufacturing processes, equipment, and general operations.

Qualifications

  • Required: High school diploma and 2 years of technical experience in Pharmaceutical, Manufacturing, or Packaging environment.
  • Required: Associate’s degree and 6 months of technical experience in Pharmaceutical, Manufacturing, or Packaging environment.
  • Preferred: Ability to follow written procedures.
  • Preferred: Capability to diagnose malfunctions and perform equipment setup.
  • Preferred: Educational Background in Mechanical, Electronic Engineering Technology or Industrial Mechanics.
  • Preferred: Working experience in GMP, Medical Device, or Biotech Manufacturing regulated environment.
  • Preferred: Ability to use computer systems to support the material inventory system (SAP transactions) and electronic batch records.
  • Preferred: Excellent attention to detail, good organization, and capable of working independently.
  • Preferred: Able to work in small groups and cross functional teams to troubleshoot issues, identify and implement collective corrective actions.
  • Preferred: Experience working with highly automated equipment.
  • Preferred: Experience working with Human Machine Interfaces (HMIs).
  • Preferred: Experience working with discrete component assembly.
  • Preferred: Good documentation planning and inventory skills.
  • Preferred: Ideal candidate will have keen eye for quality, is self motivated, and will work collaboratively within a team, and possess a positive demeanor.
  • Preferred: Knowledgeable of the following technical areas: Packaging or Process Equipment/System Maintenance.

Education

  • Educational Background in Mechanical, Electronic Engineering Technology or Industrial Mechanics.

Additional Requirements

  • Available to support operation in non-standard shift that includes weekends and/or holidays as determined by business needs.