Senior Associate Manufacturing Systems

hace 2 horas

Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completo

The Senior Associate, Manufacturing Systems (Automation) provides technical engineering support for system and equipment optimization, upgrades, replacements, and modifications. This role ensures that maintenance operations are performed in full compliance with corporate policies, industry standards, regulatory guidelines, and FDA requirements. The individual will support the maintenance team across utilities, process systems, instrumentation, calibration, and technical cleaning activities while promoting continuous improvement and equipment reliability.

KEY RESPONSIBILITIES

  • Evaluate and ensure utility systems, process maintenance, instrumentation/calibration/electrical systems, and technical cleaning systems meet all applicable industry, regulatory, and FDA standards.
  • Maintain consistency in the maintenance team's training program, standard operating procedures (SOPs), and equipment/system operational standards.
  • Support the development, execution, and continuous improvement of audit programs to ensure ongoing compliance.
  • Provide technical guidance to the maintenance team on engineering, regulatory, compliance, calibration, quality, microbial/environmental, technical cleaning, validation, electrical, and process maintenance issues.
  • Participate in system optimization strategies, equipment upgrades, and process improvements.
  • Support testing and implementation of sanitization and maintenance procedure changes for process, utility, and clean room systems.
  • Assist the maintenance team during FDA and other regulatory inspections.
  • Provide technical support in preparing responses to regulatory observations and requests.
  • Support investigations into high purity water systems and environmental monitoring alert/action notifications.
  • Partner with plant engineering to implement engineering improvements, compliance enhancements, and equipment optimization projects.
  • Facilitate routine audits and documentation reviews to maintain a state of control.

COMPETENCIES & SKILLS

  • Strong leadership & team-building abilities
  • Excellent verbal and written communication skills (including technical writing)
  • Strong organizational and facilitation skills
  • Ability to manage and adapt to change
  • Deep understanding of validation protocol requirements
  • Technical equipment expertise
  • Analytical problem-solving
  • Project management, planning, and scheduling
  • High computer literacy

Requirements

REQUIRED EDUCATION & EXPERIENCE

  • Master's degree, or
  • Bachelor's degree + 2 years of engineering experience, or
  • Associate's degree + 6 years of engineering experience, or
  • High school diploma/GED + 8 years of engineering experience.

PREFERRED QUALIFICATIONS

  • Experience with PLC programming and troubleshooting
  • Knowledge of VFDs, sensors, and automation components
  • Experience with vision systems such as Cognex, Keyence, or Systech
  • Familiarity with ABB or Fanuc robots
  • Prior experience in a regulated manufacturing environment (GMP/FDA)
  • Strong understanding of clean utilities and cleanroom systems

Benefits

  • 3-year contract
  • 12 hours shift
  • 48 hours a week

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