Validation Engineer

Overview

On Site
Full Time

Skills

Quality Management
Acquisition
Project Management
Scheduling
SOP
Metrology
Preventive Maintenance
Inventory
Auditing
Science
Good Manufacturing Practice
Analytical Skill
GMP
GDP
Attention To Detail
CMMS
Technical Writing
Communication
Collaboration
Quality Control
Quality Assurance
Microsoft Office

Job Details

Responsibilities:
  • Support team to investigate and resolve issues related to equipment failures, system deficiencies, deviations, and equipment troubleshooting.
  • Support authoring quality systems records such as deviations, change controls, and CAPAs as required
  • Monitor and communicate method lifecycle (acquisition, qualification/validation,
  • implementation) timelines using project management tools.
  • Ordering supplies and maintaining inventory for equipment consumables/accessories.
  • CTU alarm response, calibration, and re-qualification coordinating and scheduling.
  • Assist with locating and collecting assets due for service and returning to the laboratory when complete.
  • Train QC analysts in equipment operation.
  • Serve as the point person in QC for all equipment inquiries and relay to appropriate vendors.
  • Onsite and externally.
  • Perform as-needed non-invasive repairs on UHPLC systems such as changing capillaries, flow.
  • cells, needles/seats as well as perform basic troubleshooting.
  • Other responsibilities are to support team projects and proactive initiatives.
  • Author, revise, and maintain Equipment/Instrument SOP's.
  • Coordinate and schedule calibration/maintenance activities with Facilities, Metrology, and QC.
  • ensure timely completion minimize equipment down, and address OOT (Out of Tolerance).
  • Review preventative maintenance reports, calibration certifications, and CMMS records, and perform system inventory audits.
  • Submit asset induction, work, and administrative requests to ensure equipment failure.
  • Addressed immediately and information is CMMS is accurate and in proper state.
  • Attending cross-functional meetings.

Requirements:
  • Bachelor's degree in sciences and at least 5 years of industry experience in a cGMP laboratory setting.
  • Familiar with analytical equipment troubleshooting and maintenance.
  • Strong skills with GMP/GDP/QC Data review and attention to detail.
  • Familiar with CMMS systems.
  • Technical writing skills.
  • Strong communication skills (verbal and written); Ability to collaborate effectively in a dynamic.
  • cross-functional matrix environment (QC, QA, Validation, Digital, Vendors) to ensure equipment.
  • is serviced on time.
  • Experience with CTU (Controlled Temperature Units) and equipment calibration.
  • Proficiency with Microsoft Office Programs.
  • Demonstrated ability to work effectively under established guidelines and instructions.
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