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

• 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

Warm Regards,

Jay Kaushik

Clinical Recruiter

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70

Direct: (732) 429 1633

Tel:(732) 549 2030x211

Fax: (732) 549 5549

http://www.irionline.com