Operations Excellence Engineer

Hello this is Komal from Intellectt we have an opening for an Operations Excellence Engineer in Boulder, CO. Please find the job details and description below and if interested You can reach me at komal@intellectt.com or call me at 1(732)-813-9025.

Role: Operations Excellence Engineer

Location – Boulder, CO: Hybrid (on-site initially, with remote work flexibility)

Duration: Estimated 6 months (potentially longer)

Key Responsibilities

Operational Readiness Leadership:

• Lead and collaborate with the client’s internal team to develop and implement a comprehensive operational readiness plan for the new GMP manufacturing facility focused on Oligonucleotide Clinical Supplies (Phase 1 & 2).
• Ensure the facility is prepared to transition into operation upon construction completion.
  
  

Team Coordination and Training:

• Oversee the organization and execution of training programs to ensure all personnel are properly trained to operate in a GMP-compliant environment.
• Document all training activities in compliance with GMP standards.
• Supply Chain and Equipment Planning:
• Identify and ensure that all necessary supplies and resources required for the plant's operation are secured.
• Coordinate the procurement and availability of operational supplies.
  
  

GMP Documentation and Compliance:

• Ensure all readiness processes, plans, and activities are documented appropriately to meet GMP requirements.
  
  

Hybrid Working Model:

• Initially on-site to meet with the teams and understand the operational needs.
• Following the initial engagement, manage operations remotely with occasional on-site presence as needed.
  
  

Required Skills and Qualifications:

• Senior-level expertise with a strong background in manufacturing operations, preferably in synthesis processes (though not mandatory).
• Experience with operational readiness in the pharmaceutical industry, particularly in GMP-regulated environments.
  
  

Project Management:

• Strong project management skills to develop, coordinate, and execute an operational readiness plan.
• Ability to lead cross-functional teams and ensure alignment with project goals and timelines.
  
  

Regulatory Knowledge:

• Thorough understanding of GMP requirements and regulatory standards in clinical manufacturing environments.
  
  

Communication and Leadership:

• Excellent communication and leadership skills to effectively coordinate with the client’s internal team and guide them through the readiness process.