Manufacturing Operations Project Manager

Job Function and Description: 

• Actively develop, support and manage projects / activities (Project Portfolio Management) as they relate to Manufacturing operations / processes: 

• Effectively communicate project information between MFG floor and support functions 

• Provide department project updates as required 

• Review / Approve Engineering and Validation documents 

• Initiate and assist with the review of project documents and facility/equipment design documents (URS/Configuration & Functional Specifications, ICV documents, etc) 

• Lead and provide manufacturing support and coordination for capital projects, technology transfers, and continuous improvement efforts 

• Actively support shutdown scheduling activities 

• Review and approve Work Orders 

• Develop project schedule 

• Lead and actively engage within the Manufacturing Planning Process: 

• Identify and schedule project events around manufacturing operations 

• Communicate events effectively to the Scheduler and impacted groups 

• Identify materials (chemicals/disposables) required to support project execution work. (i.e.: BOM exception) 

• Provide input to future budget planning

• Own and Trend Quality System(s) in support of Manufacturing Operation projects 

• Change Control / CAPA / Action Items \

• Track status of related QS’s (Initiation – Close out) 

• Assign and manage action items – I.E.: SOP / Batch Record / Formulation Preparation Records to achieve project timelines 

• Change Control Review Board MFG representative 

• Assist in triage of open quality systems 

Education and Experience Requirements: 

• Bachelor’s Degree (or an equivalent combination of education and relevant experience) 

Requires a minimum of 5 years of experience in a Pharmaceutical Manufacturing-related field

Key Skills, Abilities, and Competencies 

• Must be proficient with Microsoft applications, including Project, Word, Excel and Power Point

• Knowledge of biopharmaceutical manufacturing processes and equipment