Client description:

Our client is a leader in the CDMO realm whose focus is to combine technical leadership in cell culture, microbial fermentation, and cell and gene therapy with world class GMP facilities to advance tomorrow's medicines.

• Opportunity to work for one of the leaders in the biotechnology industry with a focus on supporting their customers with the development and manufacturing of recombinant proteins, viral vaccines, and gene therapies.
• Strong leadership team.
• Continued investment into the development of the business as they recently just acquired $1.2 billion in funding to expand their manufacturing facilities.

Project description:

• The project is currently in the design phase. Our client is looking to add a project coordinator for their Factory Acceptance Testing for the start of their new expansion of their Greenfield site which will emulate the existing site that is now weather tight and in the process of bringing equipment in.
• The client is wrapping up the design phase of this new greenfield expansion, DSM 3 & 4.
• This individual will be working under the supervision of the director of CQV & ultimately reporting into the Lead CQV Project Manager.
• The CQV department is comprised of 130 plus contractors. Currently has 3 project coordinators supporting the CQV FAT team.

Technology environment the consultant will be working in:

Smartsheet, MS Products, Tableau

Consultants day to day responsibilities:

• Facilitating team huddles and weekly planning meetings with cross functional resources involved in the project. This includes teams both inside and outside of the CQV org.
• Working on the design phase of this greenfield build, coordinating work that is directly related to the CQV process.
• FAT Project Coordinator Is the role above (coordinating with construction and engineering
• Working closely with the QA, QC, Automation, Engineering, Validation, CapEx, EH&S, Utilities startup group, Upstream and Downstream Processing teams by running meetings and providing oversight in the project
  • Following up on action items and deliverables
  • Communicating and addressing timelines and delays with internal stakeholders
• Acting as a support resource to the PM in handling coordination, documentation, and meeting minutes
• This individual will be responsible for working in Smart Sheets and tracking deliverables for commissioning activities, action constraints, deviation resolutions
• Drive coordination of daily, weekly and monthly activities for assigned area with focus on execution, staffing coordination and area availability
• Utilization of visual management tools