Manufacturing Project Coordinator - NITTO DENKO Avecia

Purpose of Position:

• To serve as a liaison between the manufacturing team and the project management team to assure all manufacturing related activities and expectations are communicated to the direct manufacturing team.
• Act as the manufacturing representative on cross functional projects teams and communicate the relevant information required to successfully execute a manufacturing campaign

Key Responsibilities:

Originate, revise, approve, and/or review GMP documentation including but not limited to:

-Process Instructions,SOP's, Change Controls and Planned Deviations

• Complete tasks in Oracle system (including generation of product item numbers / entering raw materials required for a campaign etc)
• Review project specific documents including but not limited to:

-Manufacturing Process Outline (MPO)

- Manufacturing Process Formula (MPF)

-Project Change Controls

-Work Orders

-Project Representation

• Represent Manufacturing on Project Teams, communicating and delivering project expectations.
• Attend daily/ weekly internal and external customer meetings to report manufacturing updates.
• Keep detailed records of project campaigns
• Assist in technical and safety risk assessment and the communicate any risks to the manufacturing team.
• Assist in project specific compliance investigations.
• Interact with various functional groups and the customer to accomplish project goal
• Work with the project managers and customers to resolve Manufacturing specific questions and Process Instruction comments

Job Knowledge Required:

• This is specialist position requiring a comprehensive knowledge of the cGMP requirements for pharmaceutical manufacturing or API manufacturing
• Minimum education requirements include a science related Bachelor’s degree or equivalent work experience.
• Knowledge of biotechnology / chemical manufacturing processes and equipment is preferred

Equal Opportunity Employer