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Associate Tech Engineering

hace 4 meses

Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completo

Join BioPharma Consulting JAD Group as an Associate Tech Engineering and collaborate with a team of experts in the field. The Associate Technical Engineer will provide comprehensive automation support to optimize system and equipment performance, manage upgrades, replacements, and modifications, and ensure compliance with corporate policies, industry standards, regulatory standards, and FDA requirements.

Responsibilities:

  • Evaluate and ensure utility systems, process maintenance, instrumentation/calibration/electrical systems, and technical cleaning systems comply with industry, regulatory, and FDA standards.
  • Collaborate with TECHSUPPORT on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process automation issues.
  • Support FDA and other regulatory agency inspections and provide TECHSUPPORT for regulatory responses.
  • Assist in evaluating and implementing engineering improvements, policy changes, compliance enhancements, and optimization programs.
  • Perform other duties as assigned.

Competencies and Skills:

  • Leadership and team building
  • Verbal and written communication (Technical Writing)
  • Organization and facilitation
  • Change management
  • Comprehensive understanding of validation protocol requirements
  • Technical expertise (Equipment Specific)
  • Analytical problem-solving
  • Project management and planning
  • Scheduling
  • Computer literacy

Requirements

Education and Experience:

  • Bachelor's degree or
  • Associate's degree with 4 years of directly related experience, or
  • High school diploma/GED with 6 years of directly related experience.

Preferred Qualifications:

  • Experience with Packaging Equipment such as Thermoformer, Cartoner, Case Packer, Labeler
  • Familiarity with assembled equipment, Vision Systems, Serialization, Sensors, Cobots
  • Skills in mechanical adjustment, motor replacement, VFD, PM, train tools, PLC backup, pneumatic and electrical/mechanical troubleshooting

Additional Information:

  • Must be able to work 12-hour shifts as specified.
  • Ability to adapt to varying schedules and demands.