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