Engineer

hace 1 mes


Juncos, Puerto Rico BioPharma Consulting JAD Group A tiempo completo

Summary:
Under general supervision, this role provides technical expertise in process optimization, operational troubleshooting, and/or the execution of capital projects within manufacturing, pilot plant, or operations environments. The Operations/Design Engineer applies fundamental engineering principles to system design, troubleshooting, and process improvements while collaborating with cross-functional teams to achieve objectives.

Responsibilities:

  • Solve technical problems of moderate scope and complexity using standard engineering techniques and procedures.
  • Perform technical assignments requiring investigation of limited variables to meet specific objectives.
  • Initiate and complete routine technical tasks and support operational and engineering projects.
  • Serve as a technical expert for equipment and systems, providing troubleshooting support to maintain schedules and resolve complex issues.
  • Audit operational performance and ensure regulatory compliance for moderate to complex equipment and systems.
  • Collaborate with cross-functional teams (research, manufacturing, maintenance, process development, facilities, quality assurance, validation) to develop system modifications and enhancements.
  • Assist project managers in completing design, engineering, and construction projects within schedule and budget constraints.
  • Work with consultants, architects, and engineering firms to develop standard design documents.
  • Critique vendor quotes, generate project cost estimates, and create schedules for equipment modifications or installations.

Skills:

  • Problem-solving and analytical capabilities.
  • Technical report writing and presentation skills.
  • Hands-on experience with specialized laboratory equipment.
  • Strong understanding of validation protocol execution.
  • Personal organization and adaptability to manage change.
  • Computer literacy and ability to leverage technology for self-learning.

Requirements

Qualifications:

  • Education: Master’s degree OR Bachelor’s degree in Engineering with 2+ years of engineering experience.
  • Preferred Fields: Chemical, Mechanical, or Electrical Engineering.
  • Experience: Preferably in GMP-related fields such as manufacturing or engineering operations.

Preferred Qualifications:

  • Understanding of pharmaceutical/biotech manufacturing processes and validation protocols.
  • Experience with documentation in a regulated (GMP) environment.
  • Familiarity with manufacturing equipment, including valves, pumps, utilities, and control systems (e.g., PLC).
  • Experience in drug substance/API operations, equipment start-up, and troubleshooting.
  • Knowledge of failure modes and the ability to propose resolutions.

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