Manufacturing Process Expert

hace 1 mes


Juncos, Puerto Rico Mirus Consulting Group A tiempo completo
About Mirus Consulting Group

Mirus Consulting Group is a reputable company based in Puerto Rico, specializing in computer system validation and information technology consulting services. They cater to pharmaceutical companies and other organizations across the island and parts of the United States.

Job Title: Manufacturing Process Expert

This role requires an individual with expertise in manufacturing operations to support the execution of quality systems, including non-conformances, process validation, procedures, training, and new product introductions.

Key Responsibilities:
  • Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
  • Serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
  • Initiate, revise, and approve manufacturing procedures, ensuring they reflect current operations, and serve as a document owner.
  • Assess process performance by observing floor operations and reviewing performance data, evaluating, planning, and implementing solutions for process improvement opportunities.
  • Provide troubleshooting support and assist in generating training materials and providing training on scientific or technical aspects of the process.
Process Monitoring:
  • Support establishment of process monitoring parameters and control limits.
  • Collect process-monitoring data and support the assessment of deviations.
  • Provide support for timely execution of process monitoring quarterly reports.
Non-Conformance and CAPA:
  • Evaluate and resolve non-conformances within established goals.
  • Author investigation reports, execute corrective actions, and manage NC/CAPA closure within established goals.
  • Monitor and communicate incident trends, review equipment/system Root Cause Analysis investigations, and support trend evaluations.
Process Validation:
  • Assist in generating process validation protocols and reports.
  • Execute process validation and support collection and analysis of process validation data.
Regulatory Compliance:
  • Participate in regulatory inspections.
New Product Introductions & Process or Equipment Modifications:
  • Participate in NPI processes to assess requirements for documentation, materials, training, and equipment modifications.
  • Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
Change Control:
  • Collaborate with manufacturing change owners on CCRB packages impacting the process.
Education Requirements:

A Doctorate degree, Master's degree with 3 years of experience, Bachelor's degree with 5 years of experience, Associate's degree with 10 years of experience, or High school diploma/GED with 12 years of experience in Manufacturing Operations are required.

Salary Estimate:

We offer a competitive salary range of $60,000 - $90,000 per annum, depending on qualifications and experience.



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