Demo

Equipment Analyst

Insight Global
Malvern, PA Full Time
POSTED ON 2/8/2025 CLOSED ON 5/4/2025

What are the responsibilities and job description for the Equipment Analyst position at Insight Global?

Title : ELM Analyst (Equipment Lifecycle Management)

Location : Malvern, PA At least 1 day WFH – fully onsite to start, after training 1 day WFH.

Duration : 1 year - 10 PTO days, 6 sick days

Hours : Core 9-3 (8 hours from there)

Compensation : $31-$40 / hr Exact compensation may vary based on several factors, including skills, experience, and education.

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and / or other paid time off as provided by applicable law

Interview Process : 2 rounds, 1 virtual

Ideal start date : ASAP!

  • What experience is required?
  • Instrumentation
  • IQ OQ
  • HPLC : cell counters, plate readers, flow cytometers, DNA sequencing
  • GMP – must have
  • 21 CFR preferred
  • Tech : SAP, Meridian, KNEAT, Comet, Empower - all preferred
  • Technical writing - creating new SOPs for new instruments and updating existing ones

Requirements :

  • Bachelor degree in Scientific field
  • Minimum 4 years of experience working within a Quality GMP environment with troubleshooting exposure of equipment – USP, EP and Compendial standards
  • Minimum 4 years of experience with qualification of GMP instrumentation
  • Excellent GxP understanding
  • Strong experience utilizing Microsoft Office
  • Go-getter personality with team-oriented mindset
  • Preferred :

  • Empower, Trackwise or Comet experience
  • Experience with technical writing writing protocols and procedures, validation documentation
  • Experience working with 21 CFR Part 11 assessment or ANNEX 11 assessment

    Day to Day : One of our large pharmaceutical clients is looking to hire an Qualification Analyst for the Equipment Lifecycle Management team within the Quality department. This individual will be responsible for following Quality Control procedures on the installation, qualification, and maintenance of GMP analytical instruments in 5 Quality labs in Malvern PA. Responsibilities will include :

  • Leading and participating in cross-functional teams.
  • Communicating with vendors to coordinate maintenance and troubleshooting activities.
  • Must follow Good Documentation practices.
  • Draft and execute instrument qualification protocols, site operating procedures, and other technical documents with minimal guidance once trained on internal processes.
  • Draft protocols, supporting documents, and procedures for new instruments and equipment.
  • Write and execute QC analytical equipment qualifications
  • Connect with QA to follow up on investigations to understand the root cause
  • Overall Equipment lifecycle management
  • Day to day – a lot of PM – vendor escorts, handling the scheduling the PMs – still need to figure out – more focused on the day to day or the validation work
  • PM – equipment breakdowns, communicating with external vendors
  • minor troubleshooting – not too technical
  • Salary : $31 - $40

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