Fujifilm Manufacturing USA, Inc

CQV Engineer 2

Fujifilm Manufacturing USA, Inc • $75K — $95K *
Holly Springs, NC 27540In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering with 2 years of experience in validation activities
  • Familiarity with Good Manufacturing Practices (cGMP)
  • Experience in a highly regulated industry
  • Knowledge of mammalian cell culture processes (preferred)
  • Master's degree in Engineering with no prior experience (preferred)

Responsibilities

  • Configure, test, and validate electronic systems for compliance
  • Read piping & instrumentation diagrams to assess systems
  • Draft and implement validation protocols
  • Coordinate execution of validation activities including equipment setup
  • Generate calibration reports and maintenance plans in CMMS
  • Execute validation protocols for various types of equipment
  • Develop dashboards in Tableau for CQV data visualization

Benefits

  • Opportunities for career development and training
  • Access to cutting-edge technology and equipment
  • Collaborative work environment fostering innovation
  • Support for work-life balance initiatives
  • Potential for advancement within a growing company
Full Job Description
Position Overview

The CQV Engineer 2 supports the commissioning and qualification of equipment and systems for the site. This role coordinates with the CQV team to perform validation activities to include but not limited to equipment set up, building dashboards, and reading and reviewing documents. This role ensures equipment and systems comply with regulatory requirements and quality standards.

Job Description

  • Configures, tests, and validates electronic systems to ensure the systems are properly qualified and validated per standards and regulatory requirements (e.g., Food & Drug Administration (FDA))
  • Reads piping & instrumentation diagrams (P&IDs) to walkthrough systems in the field
  • Drafts and implements validation protocols
  • Coordinates the execution of validation activities (e.g., equipment set up, material readiness, and work orders)
  • Creates work orders, generates calibration reports, maintenance plans, and other items in the computerized maintenance management system (CMMS)
  • Executes validation protocols for manufacturing equipment, lab and admin, process support equipment, etc.
  • Develops dashboards in Tableau to visualize and analyze CQV data to track progress and trends
  • Identifies potential risks and escalates to senior engineers or management for resolution
  • Creates, implements, and maintains equipment and system qualifications and validation protocols
  • Prepares and presents report packages for implementation into standard operating procedure (SOPs)
  • Prepares validation master plans for facilities, equipment, and systems
  • Other duties, as assigned

Minimum Qualifications:
  • Bachelor's degree in Engineering with 2 years of experience in validation activities in facilities, commissioning, and systems qualifications

Preferred Qualifications:
  • Master's degree in Engineering with no prior experience
  • Prior experience with Good Manufacturing Practices (cGMP) or working in another highly regulated industry
  • Prior experience with mammalian cell culture process

About Fujifilm Manufacturing USA, Inc

Fujifilm Manufacturing USA, Inc is a subsidiary of Fujifilm Holdings Corporation, a Japanese multinational conglomerate that specializes in imaging and photography. Fujifilm Manufacturing USA, Inc is responsible for the manufacturing of photographic paper, film, and other imaging products in the United States. The company was established in 1988 and has its headquarters in Valhalla, New York. Fujifilm Manufacturing USA, Inc operates as a subsidiary of Fujifilm North America Corporation.
Learn more about Fujifilm Manufacturing USA, Inc
Size
72,332 employees
Industry
Manufacturing & Automotive
NASDAQ
FUJIF
* Ladders Estimates

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