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Job Details

All Jobs / Req# NOVRJP00011968
Req Number:
NOVRJP00011968
Req Title:
Engineering Specialist
Client:
A Major Pharma Company
Work Address:
Morris Plains, NJ
Req Release Date:
07/10/2024
Duration:
11 months
Hours a week:
40 Hours
Position Summary

Title: Asset Lifecycle Lead

Responsible for the management of the Asset Lifecycle Program for all equipment, systems, facilities and utilities at the Morris Plains site from procurement through decommissioning.

Major Accountabilities:

  • Manage the Asset Lifecycle Program for all equipment, systems, facilities and utilities from procurement through decommissioning, including the following main functions:
  • Serve as the primary subject matter expert for the Asset Lifecyle Program.
  • Utilize Computerized Maintenance Management System (CMMS) to manage the following aspects of the Asset Lifecycle program:
  • Enrollment/Installation
  • Initial Entry into Service
  • Removal & Return to Service
  • Changes/modifications to assets, including relocation, repairs and parts replacement
  • Scheduled events (e.g. calibration, preventative maintenance) and related Work Plan Templates, Measurement Data Templates and Sensor Risk Assessments
  • Work requests/work orders, including processing, generation, tracking and follow-up; ensure work order completion, review, approval and close-out.
  • Decommissioning
  • Manage Master Data for equipment object management in Manufacturing Execution System (MES)
  • Manage Standard Operating Procedures (SOPs), Work Procedures (WPs) and Forms related to Asset Lifecycle (e.g., equipment operation, calibration and preventative maintenance) including revisions and periodic reviews.

Key Performance Indicators:

  • On-time project completion
  • Engineering KPIs
  • Change Control KPIs
  • Customer satisfaction
  • Avoidance of critical observations during internal/external inspections
Qualifications:

Education: BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.

Languages: Fluent in speaking / writing in English

Experience:

  • Experienced in a GMP regulated environment (pharmaceutical preferable).
  • Minimum 5 years of asset lifecycle experience.
  • Experience with manufacturing and laboratory equipment and change controls.
  • Experience with Computerized Maintenance Management System (Blue Mountain Regulatory Asset Management preferable)

Other Qualifications:

  • Strong oral and written communication skills
  • Ability to work independently with minimal direction
  • Self-directed and able to manage competing priorities
  • Strong computer skills
  • Ability to focus on a variety of issues and drive to results
  • Ability to interact with a variety of organizational levels and foster cross-functional and cross-cultural team
  • Knowledge with manufacturing quality (manufacturing, equipment, facilities, critical systems, automation, validation, etc.)
  • Experience with Quality Assurance, CAPA, Change Control, Document Control, Training Systems
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