Mechanical Completion Supervisor

Contract
USA
Posted 6 months ago

Mechanical Completion Supervisor

 

Description

This project consists of a 160,000 square foot production facility based in Michigan, US. Groundbreaking has begun in 2021, with a view for construction to be completed in the end of 2023, and turnover to Operations in 2025.

Reporting to the CQV Lead, the role of the Mechanical Completion Supervisor is to manage the interfaces between CQV teams and the project Construction Management Teams. The role also requires supporting the Utilities CQV workstream as required in support of static and dynamic verification of Clean and Black utilities.

 

Responsibilities

  • Manage project execution from design (concept, preliminary and detailed), selection and award of design & construction contracts, construction, commissioning & verification, operational readiness and project close out.
  • Operate according to SOPs developed for MAP Project Qualification strategy and general GEP / cGMP compliance.
  • Supervise and manage interface between Construction Management team and CQV team to ensure project Mechanical Completion is delivered as per schedule.
  • Review and approve all Construction Turnover requirements, Pre-Commissioning, Commissioning and Verification documentation as directed by the project systems list.
  • Collaborate with matrix organization to optimize Construction Turnover requirements and Equipment Verification documentation.
  • Attend weekly meetings to report on progress and set up meetings as required.
  • For specific Utilities, Provide or arrange for development of complete verification documentation in accordance with site Quality Standards and cGMP requirements for assigned projects.
  • Develop and implement changes required to resolve deviations/ non conformances associated with construction turnovers effectively.
  • Participate in design review for new/ modified utility systems.
  • Participate in construction system mechanical completion walkdowns.
  • For specific Utilities, Perform execution of Qualification Protocols (VTPs) in field.
  • Assist with pre and post study calibration verifications.
  • Assist with execution of Utility Passivation’s as per Engineering requirements.
  • Effectively interact with leadership and partner with Engineering Verification, Engineering Project Management, Automation, Maintenance, Operations, and Quality stakeholders to establish priorities and define verification documentation and testing requirements for the portfolio of systems within the assigned area.
  • Adjust day-to-day role requirements depending on the immediate demands and requirements set down by the project as a whole.
  • Work with all other project personnel to ensure successful project delivery.

 

Requirements

  • Education: Minimum of a Bachelor of Science (BS) Degree in Engineering or Related Discipline from a fully accredited institution.
  • Experience: Minimum of 9 years of engineering construction turnover and/or project management experience in Clean & Black Utility Verifications.
  • Communication Skills: Excellent oral and written communication skills, including presentations.
  • Experienced in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements.
  • Ability to write clearly, concisely, and persuasively in a professional environment.

 

To apply contact Kevin Cronin on +353 87 162 9928. 

Email CVs to kcronin@mile.ie

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