PTS Project Manager 9/6/2016

Global Pharma Tek Lexington, MA

Company
Global Pharma Tek
Job Classification
Full Time
Company Ref #
29571346
AJE Ref #
576104456
Location
Lexington, MA
Job Type
Regular

JOB DESCRIPTION

APPLY
TITLE: PTS Project Manager IV

LOCATION: US-MA-Lexington

DESCRIPTION:

PRIMARY DUTIES
Reporting to Manufacturing Operations the Project Manager will lead projects of various complexities to support departmental initiatives and participate in various cross-functional teams to support process improvements.
Responsibilities

% of Time Job Function and Description
50% Actively develop, support and manage projects / activities (Project Portfolio Mgmt) 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
20% 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
30% 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

* Bachelors Degree (or an equivalent combination of education and relevant experience)
* Requires a minimum of 5 years of experience in a Pharmaceutical Manufacturing-related field.