Senior Engineer: Parenteral Manufacturing & Vision

Mirus Consulting Group

Juncos (PR)

On-site

USD 110,000 - 150,000

Full time

5 days ago
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Job summary

mîrus Consulting Group is a local firm in Humacao, Puerto Rico offering validation and IT consulting for pharmaceutical clients. We seek a Senior Engineer to lead commissioning, qualification, and lifecycle activities for manufacturing equipment and systems within a regulated pharma environment.

The role requires expertise in parenteral processes, vision inspection systems, device assembly and packaging, including automatic and HMLV production lines, to ensure compliance and reliable product

Qualifications

  • Doctoral, master’s, or bachelor’s degree in Engineering with required years of experience.

Responsibilities

  • Lead commissioning, qualification, and validation activities for manufacturing equipment, utilities, and automated systems.
  • Develop, execute, and approve IQ, OQ, PQ protocols and related documentation.
  • Provide engineering support for parenteral manufacturing processes ensuring GMP compliance.
  • Support implementation, startup, and optimization of vision inspection systems in pharma/medical device operations.
  • Lead engineering activities for device assembly and packaging equipment, including automatic and HMLV lines.
  • Collaborate with Manufacturing, Quality, Validation, Maintenance, and Regulatory Affairs for project execution.
  • Support investigations, change controls, CAPAs, deviations, and risk assessments related to equipment and processes.
  • Evaluate equipment performance and identify opportunities for process improvements and efficiency.
  • Ensure activities adhere to safety, quality, and compliance requirements.

Education

Doctorate Degree in Engineering
Master's Degree in Engineering and 2 years of Engineering experience
Bachelor's Degree in Engineering and 4 years of Engineering experience

Job description

mîrus Consulting Group is a local firm in Humacao, Puerto Rico offering validation and IT consulting for pharmaceutical clients. We seek a Senior Engineer to lead commissioning, qualification, and lifecycle activities for manufacturing equipment and systems within a regulated pharma environment.

The role requires expertise in parenteral processes, vision inspection systems, device assembly and packaging, including automatic and HMLV production lines, to ensure compliance and reliable product

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