USA Engineering Specialist

2 hours ago

Morris, United States Abacus Full time
Job Title: USA Engineering Specialist

Abacus is seeking a highly skilled USA Engineering Specialist to join our team. As a key member of our organization, you will be responsible for ensuring compliance to regulatory requirements of facilities, utilities, equipment, and analytical instruments qualification processes and activities performed in our Client, Morris Plains, NJ facility.

Key Responsibilities:
  • Ensure compliance to regulatory requirements of facilities, utilities, equipment, and analytical instruments qualification processes and activities.
  • Recommend and implement improvements of the qualification process.
  • Perform routine and non-routine tasks related to facilities, utilities, equipment, and analytical instruments qualification.
  • Prepare risk and impact assessments and other evaluations.
  • Support 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.
  • Provide leadership and guidance to complex qualification activities and projects.
  • Manage multifaceted qualification activities with limited oversight.
  • Coordinate Qualification activities in compliance with corporate policy, local procedures, and regulatory expectations.
  • Collaborate with PU, MS&T, OPS, QC, and QA Teams on qualification projects and plans and identifies the "critical to quality" parameters impacting qualification activities.
  • Prepare Qualification Master Plans, Risk and Impact Assessments, Protocols, and Summary Reports and coordinates review and approvals of the documents.
  • Author/review/update/assist in developing departmental standard operating procedures (SOPs) and qualification programs.
  • Conduct field execution of Installation, Operational, and Performance Qualification protocols.
  • Assist PU, MS&T, OPS, QC, and QA colleagues, as necessary.
  • Ensure that all activities are in compliance with cGMP, Health Authority regulations, and the Client Policies.
  • Determine Qualification requirements based on a worst-case matrix approach for the site.
  • Provide qualification solutions that meet regulatory requirements within budget, where applicable.
  • Support/assist 3rd party/vendor qualification activities, if applicable.
  • Support qualification/validation projects as allocated.
  • Provide guidance and support of less knowledgeable qualification/validation associates.
Key Performance Indicators:
  • Conformance to the qualification KPIs.
  • Adherence to project schedule restrictions.
Ideal Background:

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

Languages: Fluent in speaking/writing in English.

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

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