Staff Qualification Engineer

Description:





Staff Qualification Engineer





On-site





Job Purpose:





Responsible for ensuring compliance to the regulatory requirements of the facilities, utilities, equipment and analytical instruments qualification processes and activities performed in the Client, Morris Plains, NJ facility. Recommends and implements improvements of the qualification process. Performs a variety of routine and non-routine tasks related to facilities, utilities, equipment and analytical instruments qualification, as managing and overlooking qualification projects and changes. Prepares risk and impact assessments and other evaluations. Supports Process Unit (PU), Manufacturing, Science and Technology (MS&T), Operations (OPS), Quality Control (QC) and Quality Assurance (QA) departments.





Major Accountabilities:





" Support internal and external audits by taking lead role on validation/qualification discussions.





" Provides leadership and guidance to complex qualification activities and projects





" Manages multifaceted qualification activities with limited oversight





" Coordinates Qualification activities in compliance with corporate policy, local procedures and regulatory expectations





" Collaborates with PU, MS&T, OPS, QC and QA Teams on qualification projects and plans and identifies the "critical to quality parameters impacting qualification activities





" Prepares Qualification Master Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the documents





" Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) and qualification programs





" Conducts field execution of Installation, Operational and Performance Qualification protocols





" Assists PU, MS&T, OPS, QC and QA colleagues, as necessary





" Ensures that all activities are in compliance with cGMP, Health Authority regulations and the Client Policies





" Determines of Qualification requirements based on a worst case matrix approach for the site





" Provides qualification solutions that meet regulatory requirements within budget, where applicable.





" Supports/assists 3rd party/ vendor qualification activities, if applicable.





" Support qualification/validation projects as allocated.





" Provides guidance and support of less knowledgeable qualification/validation associates





Key Performance Indicators:





" Conformance to the qualification KPI's





" Adherence to project schedule restrictions





Ideal Background:





Education: BS degree in Scientific discipline or other related field with significant prior experience (10+ years).





: Fluent in speaking / writing in English





Experience:





10+ years of Pharmaceutical industry qualification experience with a strong focus on Equipment and Analytical Instruments.





Hours per Day


7.5





Hours per Week


37.5





Total Hours


2,385.00